MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-19 for PERIFIX manufactured by B. Brawn Medical, Inc..
[18894]
Epidural catheter placed for anesthetic adminstration at l2 - l3. Encountered resistance when removing the catheter post operatively. 0. 5 cm of catheter retained in patient when catheter finally removed. No untoward effects noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25745 |
| MDR Report Key | 25745 |
| Date Received | 1995-01-19 |
| Date of Report | 1994-11-25 |
| Date of Event | 1994-11-10 |
| Date Facility Aware | 1994-11-23 |
| Report Date | 1994-11-25 |
| Date Reported to Mfgr | 1994-11-25 |
| Date Added to Maude | 1995-09-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIFIX |
| Generic Name | CESK - CUSTOM EPIDURAL ANESTHESIA CATHETER |
| Product Code | MAJ |
| Date Received | 1995-01-19 |
| Lot Number | #649210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26346 |
| Manufacturer | B. BRAWN MEDICAL, INC. |
| Manufacturer Address | 824 12TH AVENUE BETHLEHEM PA 18018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-01-19 |