CESIUM-137 TUBE SOURCE CDCTI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-25 for CESIUM-137 TUBE SOURCE CDCTI manufactured by Amersham Corp..

Event Text Entries

[5445] It is extremely difficult to read the serial numbers on the tube sources. The only way is to hold them very close, using magnifiers. This results in radiation doses to the eye which are excessive. Since mfr is currently the sole provider of these sources, they should be compelled to make the serial numbers easily discernable like another mfr's were before they stopped making them. The us nrc requires that positive source id be made routinely, before and after each use. Thus, personnel using the sources are routinely exposed to high dose rates. Additionally, the barely-legible serial numbers can easily be confused, and the potential for inserting a wrongly-identified source into a pt is significant. The whole problem can easily be avoided by marking the sources with larger id numbers.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1003185
MDR Report Key15529
Date Received1994-08-25
Date of Report1994-08-16
Date of Event1994-06-01
Date Added to Maude1994-08-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHYSICIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCESIUM-137 TUBE SOURCE
Generic NameCESIUM-137 TUBE SOURCE
Product CodeIWH
Date Received1994-08-25
Model NumberCDCTI
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key15521
ManufacturerAMERSHAM CORP.
Manufacturer AddressARLINGTON HEIGHTS IL 60005 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1994-08-25

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