MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-09 for 21-3000 manufactured by Pharmacia Deltec, Inc..
[17906116]
Patient heard "pop" while fushing line - exploratory lap revealed 3-4 mm tear in catheter. Catheter was placed 7/15/92. Conclusion reached was the catheter burst during the flushdevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: end of life - premature, telemetry failure. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2746 |
| MDR Report Key | 2746 |
| Date Received | 1993-01-09 |
| Date of Report | 1992-08-19 |
| Date of Event | 1992-08-07 |
| Date Facility Aware | 1992-08-17 |
| Report Date | 1992-08-19 |
| Date Reported to Mfgr | 1992-08-19 |
| Date Added to Maude | 1993-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PORTA CATHETER |
| Product Code | LLD |
| Date Received | 1993-01-09 |
| Catalog Number | 21-3000 |
| Lot Number | 17798 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 01-MAR-92 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 2561 |
| Manufacturer | PHARMACIA DELTEC, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-01-09 |