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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 5200914 June 2016 07:00:00Agreement StateAgreement State Report - Lost and Found Brachytherapy SeedsThe following was received from the State of Washington via email: (A common carrier) lost 252 IsoRay Cesium-131 brachytherapy seeds intended for four patient implants. On Friday, 6/9/2016, radioactive materials licensee, IsoRay (WN-L0213-1) sent four orders of cesium-131 brachytherapy seeds. The four orders contained a total of 252 seeds at a total air kerma activity level of 522.8 U. The total apparent activity is approximately 1 Ci (the actual activity is between 1 - 2 Ci). The absorbed dose from the 252 seeds would be approximately 52,280 rad (522.8 Gray). Early Tuesday morning, 6/14/2016, the Memphis hub of (the common carrier) informed IsoRay that they were unable to locate these packages, and they would not be delivered on time as contracted. They were scanned in and out at both the Pasco and Spokane airports. The Spokane flight to Memphis arrived, but (the common carrier) could not locate them. IsoRay notified the state of the loss of radioactive material that same day. On 6/15/2016, IsoRay notified the state that (the common carrier had) found the missing shipments and are returning them to IsoRay. They were not delivered to the intended physicians. There are no details yet on how they became misplaced. IsoRay has scheduled a senior management meeting with (the common carrier's) Priority Alert team to trouble shoot the missing shipments. This incident is one of several incidents in which (the common carrier) played a role within the last 4 months. Incident Number: WA-16-027
ENS 517094 February 2016 08:00:00Agreement StateAgreement State - Lost Shipment of Cs-131 Brachytherapy Seeds

The following report was received from the Washington Department of Health, Office of Radiation Protection via email: (On) 2/4/16, (a common carrier) has lost track of a RAM (radioactive material) Cs-131 brachytherapy seed shipment sent for a patient near Atlanta, GA. The seeds did not reach their destination in time for the implant in a patient at a clinic approximately 1 to 1.5 hrs from Atlanta, so the customer alerted IsoRay. According to IsoRay's Radiation Safety Officer, (the common carrier) is looking for the package. (The common carrier) thinks there is a possibility that the shipment may have been mistakenly transferred from the (common carriers) plane to the US Postal Service at the air field in Atlanta. IsoRay's Radiation Safety Officer called Washington State at (approximately) 9:40 AM (EST) to report the loss. Additional information is forthcoming. Washington Incident Number: WA-16-004

  • * * UPDATE FROM ANINE GRUMBLES TO DANIEL MILLS AT 1750 EST ON 2/08/2016 * * *

The following was received from Washington via email: Quantity of seeds in order: 48 Air kerma strength in micrograys per sq. meter/hr (U) - 2.02 - 2.08 = total 98 U Total apparent activity= 154 mCi (range from 3.17 - 3.26 mCi/seed) T1/2 = 9.69 days (half-life) Notified R4DO (O'Keefe), NMSS_EVENTS_NOTIFICATION (email), and CNSC Canada (email).

  • * * UPDATE FROM ANINE GRUMBLES TO DANIEL MILLS AT 1640 EST ON 2/17/2016 * * *

The following was received from Washington via email: According to the Radiation Safety Officer at the seed manufacturer/distributor, IsoRay, the US Postal Service delivered the lost package to the intended user at the end of last week. The source had decayed to the point of being useless. The customer is going to send shipment back IsoRay.' Notified R4DO (Vasquez), NMSS_EVENTS_NOTIFICATION (email), and CNSC Canada (email). THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

ENS 4488919 February 2009 08:00:00Agreement StateImproperly Packaged Radioactive MaterialThe following was provided by the state via email: A single Cs-131 Brachytherapy seed was put back into the 'mick' cartridge by Banner Baywood Medical Center in Mesa, AZ, - the medical customer and end-user - and then returned to the manufacturer, IsoRay, a Washington State seed manufacturing licensee. When the shipping container, holding the mick container, arrived at IsoRay, contamination was found on the inside of the shipping container but not on the outside. There was no damage to the shipping container. While unpacking the seed, a technician noticed there was visible damage to the seed. The tech monitored the packing material and found contamination. The RSO determined that a few microcuries of radioactive material leaked onto the packing material. The remaining millirem of material was in the damaged source and the pig. No material was missing. IsoRay called Washington State, Office of Radiation Protection, and reported the event that day. There was no contamination found at the customer's site. IsoRay's Radiation Safety Officer reported that the seed had been visibly damaged, as if sheared. This may have happened when it was returned to the mick container or when the mick cartridge was re-inserted into the pig. Since all the contamination was inside the shipping container, it is doubtful that any personnel exposure was received. The cartridge was a Mick Radio-Nuclear Instruments, Inc catalog number 0216-DS. The SS&D registration for the seed is WA-1220-S-101-S." Incident Number: WA-09-006
ENS 439551 February 2008 08:00:00Agreement StateAgreement State Report - Depleted Cesium-131 Seeds Lost from Damaged Package During Shipment

The State provided the following information via email: The Licensee reported by phone that at 2:30 PST today a package of returned and depleted implant seeds containing Cs-131 with a 9.7 day half-life was found damaged upon receipt with some of the contents missing. The package was to have contained 15 seeds that were returned from a customer on the east coast. When the package arrived, the licensee upon receipt inspection noted the package had a hole in it that had been repaired with tape. The receipt inspection also detected higher than expected dose rates at slightly less than 1 mr/hr contact with the package. The package was taken to a controlled area suitable for bio-hazard work and opened by the RSO. The package was opened and discovered with loose seeds in the box. 11 seeds were recovered, 4 seeds are missing. An Isoray facility survey was performed between the receiving area and the controlled area where the package was opened. No additional seeds were located. The sender of the package is being contacted as well as the RSO for FedEx. Highest dose rate on contact with a single seed was 1 mr/hr. The seeds were reported to have aged seven half-lives as of this day and at 1/100th of original strength. The Licensee will update our office (the State of Washington) with additional information when it comes available. The State does not know who originated the shipment or the initial strength of the CS-131 before the seven half-life decay. Washington State Report Number: WA-08-007

* * * UPDATE FROM ARDEN SCROOGS TO BILL HUFFMAN ON 2/4/08 AT 1504 EST VIA E-MAIL  * * * 

The shipment originated from Geisenger Health in Danville, PA, and was shipped by FedEx. The original strength of the seeds was nominally 4 to 5 millicuries each, or 14 to 20 for the four missing seeds. At seven half-lives, the strength would be approximately 1/100th of the original strength, or 40 to 50 microcuries. R4DO (Mike Shannon), FSME EO (Larry Camper), ILTAB (Matt Hahn), and R1DO (Christopher Cahill) informed.

* * * UPDATE FROM ARDEN SCROOGS TO KARL DIEDERICH ON 2/11/08 AT 1134 EST VIA E-MAIL  * * * 

The receipt inspection detected higher than expected dose rates at ~1.7 mR/hr contact with the package. Detailed Carrier Information from with delivery route and timeframe. Jan 29, 2008: 4:15 PM - Picked up in Montoursville, PA. 7:51 PM - left Montoursville, PA. 11:46PM - Arrived FedEx location in Newark, NJ. Jan 30, 2008: 8:38 AM - Departed FedEx location in Newark, NJ. 10:41AM - Arrived FedEx location in Memphis, TN. 3:36 PM - Departed FedEx location in Memphis, TN. 6:35 PM - At sort facility in Spokane, WA. 8:49 PM - At local FedEx facility in Spokane, WA. Jan 31, 2008: 9:52 AM - On FedEx vehicle for delivery Pasco, WA. 11:46AM - Delivered. R4DO (Dale Powers), FSME EO (Michelle Burgess), ILTAB (Jim Whitney), and R1DO (Glenn Dentel) informed. THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. This source is not amongst those sources or devices identified by the IAEA Code of Conduct for the Safety & Security of Radioactive Sources to be of concern from a radiological standpoint. Therefore is it being categorized as a less than Category 3 source

ENS 428764 October 2006 13:30:00Agreement StateWashington Agreement State Report - Two Damaged Shipping Packages Containing Cesium-131 Cancer Therapy Seeds.

Event sent to NRC Headquarters Operation Center via e-mail. ABSTRACT: (where, when, how, why; cause, contributing factors, corrective actions, consequences, Dept. of Health (DOH) on-site investigation; media attention): At 6:30 am, 4 October, the Spokane FedEx Terminal Manager discovered a flattened lead cap. A partial label on the cap indicated it came from one of two packages containing IsoRay, Cesium 131, therapy seeds. A second package was found crushed but essentially intact; the seeds in this package were all present and apparently undamaged. Scraps from the first box were found on the runway and other pieces on the floor of a tug (airport vehicle used to move cargo). It is thought the damage was caused when the boxes were caught between moving pieces of the cargo loading equipment. The actual incident appears to have happened 12 hours earlier (about 6 pm, 3 October). Dayshift FedEx staff had apparently placed the damaged packages on the floor on the passenger side of the tug cab. Four WA Department of Health, Health Physicists responded to the scene at about 8:00 am, 4 October. IsoRay also dispatched a team of three HP technicians arriving at noon with equipment including a decontamination kit. WA Department of Health staff were able to retrieved three of the sixty-three seeds that were in the one shredded package. Several areas of contamination were also found. Measurement on the floor of the tug's passenger side was reading 150 Mr/hour with an Eberline RO2 ion chamber. Radiation measurements on the crushed pig lid were about 25 Mr/hour with an RO2 and a contamination measurement of about 400 cpm with a GM instrument. Contamination reading on the crushed box was about 300 cpm with the GM instrument. A spot on the tarmac was found reading about 12 Mr/hour with an RO2. The undamaged stainless steel pig reads about 5 Mr/hour with an RO2. Night shift personnel were asked to return to the facility. No personnel contamination had been found at the writing of this report. WA Dept of Health and IsoRay staff continue to look for the remainder of the packaging and seeds. No news media attention yet. Notification Reporting Criteria: 10 CFR 30.50(b)(1) Isotope and Activity involved: 330 mCi, 12.2 Gigabecqerals of Cesium 131. Overexposures? (number of workers/members of the public; dose estimate; body part receiving dose; consequence): Exposures to be determined. Lost, Stolen or Damaged? (mfg., model, serial number): 3 of 63 missing seeds recovered, contamination found in tug, packaging and on the runway. The remainder of the activity is still being sought. Sealed Source and Device Registry: WA-1220-S-101-S Disposition/recovery: WA Dept of Health and the manufacturer staff are still on the scene to assist in recovery of seeds. Leak test? The seeds are leak tested prior to packaging and were within limits. Vehicle: (description; placards; Shipper; package type; Pkg. ID number) Airport tug, N/N FedEx air bill # 730 235 322 954. Release of activity? Three seeds found in the tug. Contamination found in the tug, on packaging and on the runway. Activity and pharmaceutical compound intended: N/A Misadministered activity and/or compound received: N/A Device (HDR, etc.) Mfg., Model; computer program: N/A Exposure (intended/actual); consequences: N/A Was patient or responsible relative notified? N/A Was written report provided? Not yet Was referring physician notified? N/A Consultant used? No." Washington Incident Report - WA-06-053

  • * * UPDATE FROM A. SCROGGS TO W. GOTT AT 1421 ON 10/26/06 * * *

The State provided the following update in the text of their original report via email: This is notification of an event in Washington State as reported to and investigated by the WA Department of Health, Office of Radiation Protection. STATUS: update / close Licensee: IsoRay, City and State: Facility in Richland, Washington License Number: WN-L0213-1 Type of License: Manufacturer and Distributor (of cancer therapy seeds) Date of Event: 3 October 2006 (reported 4 October 06). Location of Event: Spokane International Airport, FedEx Terminal, Spokane Washington. ABSTRACT: (where, when, how, why; cause, contributing factors, corrective actions, consequences, Dept. of Health (DOH) on-site investigation; media attention): At 6:30 am, 4 October, the Spokane FedEx Terminal Manager discovered a flattened lead cap in the plane loading area. A partial label on the cap indicated it came from one of two packages containing IsoRay, Cesium 131, cancer therapy seeds. A second package was found crushed but essentially intact; the seeds in this package were all present and found to be undamaged. Scraps from the first box were found on the runway and other pieces on the passenger side floor of a 'tug' (airport vehicle used to move cargo containers). It is thought the damage was caused when the boxes were caught between moving pieces of the cargo loading equipment. The actual incident appears to have happened 12 hours earlier (about 6 pm, 3 October 06). Dayshift FedEx staff had apparently placed the damaged packages on the floor on the passenger side of the 'tug' cab but this was unable to be verified. Four WA Department of Health, Health Physicists responded to the scene at about 8:00 am, 4 October. IsoRay also dispatched a team of three HP technicians arriving at noon with equipment including a decontamination kit. WA Department of Health staff returned Thursday, Friday and Monday to continue the investigation. WA DOH was not able to find any additional material except that found October 4. These finds amounted to three seeds and a minor amount of contamination in the tug and on the loading surface. WA DOH spent 16 FTE days looking for the material and interviewing FedEx staff. Night shift personnel were asked to return to the facility. No personnel contamination was found. All parts of the complex within the FedEx secured area (buildings and property) and public areas adjacent to the FedEx secured property were searched. IsoRay personnel decontaminated the tug and loading surface. Took control of the three recovered seeds found in the tug and took all of the damaged packaging including the second package (damaged but intact) and its contents. Measurement on the floor of the 'tug's' passenger side was reading 150 mR/hour with an Eberline RO2 ion chamber. Radiation measurements on the crushed pig lid were about 25 mR/hour with an RO2 and a contamination measurement of about 400 cpm with a GM instrument. Contamination reading on the crushed box was about 300 cpm with the GM instrument. A spot on the tarmac was found reading about 12 mR/hour with an RO2. The outside of the undamaged stainless steel pig measurers about 5 mR/hour with an RO2. Some product is transported in a lead container and some in stainless steel. The missing material was in lead; the material in the damaged second package was in stainless steel. WA Dept of Health and IsoRay staff were on site for a total of 4 days. WA DOH spent approximately 16 FTE days looking for the remainder of the packaging and material. Nothing additional was able to be located. There was a local television media news story. Notification Reporting Criteria: 10 CFR 30.50(b)(1) Isotope and Activity involved: 330 mCi, 12.2 Gigabecqerals of Cesium 131. Cesium 131 has about a 9.2 day half-life. Overexposures? (number of workers/members of the public; dose estimate; body part receiving dose; consequence): The investigation indicates it unlikely that personnel received any significant radiation exposure. However, this could not be substantiated since facility individuals were not forthcoming with information that could be used to make an exposure determination.

Lost, Stolen or Damaged? (mfg., model, serial number): 3 of 63 missing seeds recovered, contamination found in tug, packaging and on the runway. The remainder of the material was not able to be located. Sealed Source and Device Registry: WA-1220-S-101-S Disposition/recovery: WA DOH has indicated to FedEx management that hazardous materials transportation handling procedures should be revised and staff refresher training should be performed. Leak test? The seeds are leak tested prior to packaging and were within limits. Seeds from the damaged second package were found to be undamaged. Vehicle: (description; placards; Shipper; package type; Pkg. ID number) Airport tug, N/N FedEx air bill # 730 235 322 954. Release of activity? Three seeds found in the tug. Contamination found in the tug, on packaging and on the loading runway. Activity and pharmaceutical compound intended: N/A Misadministered activity and/or compound received: N/A Device (HDR, etc.) Mfg., Model; computer program: N/A Exposure (intended/actual); consequences: N/A Was patient or responsible relative notified? N/A THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks.