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..
[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
| Report Number | MW1003185 |
| MDR Report Key | 15529 |
| Date Received | 1994-08-25 |
| Date of Report | 1994-08-16 |
| Date of Event | 1994-06-01 |
| Date Added to Maude | 1994-08-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CESIUM-137 TUBE SOURCE |
| Generic Name | CESIUM-137 TUBE SOURCE |
| Product Code | IWH |
| Date Received | 1994-08-25 |
| Model Number | CDCTI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15521 |
| Manufacturer | AMERSHAM CORP. |
| Manufacturer Address | ARLINGTON HEIGHTS IL 60005 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-08-25 |