MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-27 for 21-400 manufactured by Pharmacia - Deltec.
[4389]
50 year old male with port-a-cath implantation in 4/1993. A 6 cm segment of catheter is intact at the level of the clavicle first rib. The catheter is sheared. The remaining portion of the catheter appears to be lying in the right and left pulmonary veins. Device labeled for single use. Patient medical status prior to event: satisfactory condition. 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7636 |
| MDR Report Key | 7636 |
| Date Received | 1994-01-27 |
| Date of Report | 1993-12-01 |
| Date of Event | 1993-11-17 |
| Date Facility Aware | 1993-11-22 |
| Report Date | 1993-12-01 |
| Date Reported to Mfgr | 1993-12-01 |
| Date Added to Maude | 1994-05-05 |
| 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 | PORT-A-CATH |
| Product Code | LKG |
| Date Received | 1994-01-27 |
| Catalog Number | 21-400 |
| Lot Number | 20541A |
| Device Availability | * |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 7315 |
| Manufacturer | PHARMACIA - DELTEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-27 |