ENS 42358
ENS Event | |
|---|---|
05:00 Apr 17, 2003 | |
| Title | Agreement State Report Involving a Radiopharmaceutical Misadministration |
| Event Description | The following information was received via facsimile:
NY-06-001 Radiopharmaceutical Misadministration. (NYS DOH Internal Tracking No. 86) New York law prohibits the release of any identities in cases of medical, events. Therefore the facility name, etc., is not contained in this report. Date of occurrence 4/17/2003 The patient was prescribed 300mCi of I-131 NaI for thyroid carcinoma but received only 233 mCi. Licensee received two vials from the radiopharmacy as ordered, one with 200 mCi and the other with 100 mCi. The vials were, as per Licensee's protocol, left in the outer plastic sleeve during assay, and the assays were within acceptable limits. Upon completion of administration to the patient, the vials were again assayed to access the residual activity in the vials. Nothing unusual was noted for the 100 mCi vial, however about 90 mCi remained in the 200 mCi vial. Water was added to that vial and the patient was administered that liquid portion. The vial was again assayed and about 70 mCi remained. The licensee asked the pharmacy for additional I-131 but was told that the additional dosage would not be available until the next day. Consequently the patient was released with only having received 233 of the 300 mCi prescribed. The patient and referring MD were notified. The RSO/licensee staff investigated. They noted that there was some liquid between the glass vial and its outer plastic sleeve. Upon close examination of the vial it appears that the seal between the vial and septum was flawed allowing material to 'leak' from the vial. Additional surveys of packaging and area were performed. The need for bioassays of those involved in the administration was addressed. We received copies of reports from both the medical licensee and radiopharmacy. It appears that the seal on the vial was compromised thus allowing material to move outside the vial but remain contained within the outer plastic vial. Thus it had appeared that the vial was okay for use. Bioassay and survey measurements were performed with negative results. Actions to prevent repeat of such an event were included in both reports. The licensee followed up in regard to the patient. The treating physician stated that the dose was within the therapeutic range by existing standards. The patient was subsequently retreated with 300 mCi of I-131 in August of 2004. This post-treatment scan was positive and he was advised to return again in 6 - 9 months for re-evaluation. He did not, citing difficulties relating to employment etc. However, some time later he agreed to come in for further follow-up. |
| Where | |
|---|---|
| Not Disclosed By State Law New York (NRC Region 1) | |
| Organization: | New York State Dept. Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+25017.42 h1,042.393 days <br />148.913 weeks <br />34.269 months <br />) | |
| Opened: | R. Dansereau (Via Fax) 15:25 Feb 22, 2006 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Feb 22, 2006 |
| 42358 - NRC Website | |
Not Disclosed By State Law with Agreement State | |
WEEKMONTHYEARENS 423602005-11-29T05:00:00029 November 2005 05:00:00
[Table view]Agreement State Agreement State Report Involving a Broken I-125 Brachytherapy Seed ENS 423642004-11-05T05:00:0005 November 2004 05:00:00 Agreement State Agreement State Report Involving an I-131 Radiopharmaceutical Misadministration ENS 423632004-09-29T05:00:00029 September 2004 05:00:00 Agreement State Agreement State Report Involving an Intravascular Brachytherapy Event ENS 423622004-05-26T05:00:00026 May 2004 05:00:00 Agreement State Agreement State Report Involving an Intravascular Brachytherapy Event ENS 423592003-12-14T05:00:00014 December 2003 05:00:00 Agreement State Agreement State Report Involving a Medical Misadministration ENS 423582003-04-17T05:00:00017 April 2003 05:00:00 Agreement State Agreement State Report Involving a Radiopharmaceutical Misadministration 2005-11-29T05:00:00 | |