FDA.reportPublic FDA data

MAUDE MDR 3024758

MDR report key
3024758
Report number
3024758
Event key
0
Event type
3
Date of event
2012-08-01
Date received
2013-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CO-57SOURCE, CALIBRATION, SEALED, NUCLEARECKERT AND ZIEGLER ISOTOPE PRODUCTSIXD*** R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-260

Event Narratives#

D

Patient 1

A PLASTIC VIAL CONTAINING APPROXIMATELY 3 MILLICURIES OF SOLID COBALT 57 DEVELOPED A LEAK. THE LEAK WAS DETECTED WITH A DRY WIPE TEST. THE AMOUNT DETECTED WAS EXTREMELY SMALL, IN A CATEGORY THAT MADE THE LEAKAGE NON-REPORTABLE TO THE STATE OR REGULATORY AUTHORITIES. THERE WAS NO CONTAMINATION, NO HARM TO PATIENTS OR STAFF, AND NO SPILL. THE VIAL DID NOT APPEAR TO HAVE ANY CRACKS OR DAMAGE. COBALT 57 IS A SOLID EPOXY MATRIX. THE VIAL WAS NOT DAMAGED DURING SHIPPING. IT HAD BEEN IN USE AT THE HOSPITAL FOR ALMOST A YEAR. THE PHYSICIST WHO PERFORMED THE WIPE TEST PROPERLY DISPOSED OF THE COTTON DISK. THE MANUFACTURER WAS NOTIFIED, THE VIAL WAS RETURNED TO THE MANUFACTURER FOR DISPOSAL. THE HOSPITAL RECEIVED VERIFICATION THAT THEY RECEIVED THE VIAL. THE HOSPITAL OBTAINED A REPLACEMENT. THE CAUSE OF THE LEAKAGE IS UNKNOWN.======================MANUFACTURER RESPONSE FOR VIAL OF COBALT RADIOISOTOPE, UNKNOWN (PER SITE REPORTER).======================MANUFACTURER NOTIFIED THE HOSPITAL THAT THEY RECEIVED THE VIAL FOR DISPOSAL. THERE WAS NO WARRANTY REMAINING AND THE HOSPITAL RECEIVED A REPLACEMENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NOT APPLICABLE.