MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-28 for PERIFIX CUSTOM EPIDURAL ANESTHESIA TRAY S1550316 manufactured by B. Braun Medical, Inc..
[13770]
6/13/94 epidural catheter inserted at l1-2 with subcutaneous tunneling for left low back pain, hip and leg pain. Infusion started in pain clinic. Later that evening subcutaneous swelling was noted. Appeared after testing the catheter with normal saline that there was a hole in the catheter probably as a result of the tunneling. 6/13/94 epidural catheter was removed intact. On 6/14/94 a new epidural catheter was inserted at l2-3 under sterile condition and placed subcutaneously. Patient was discharged home in satisfactory condition. Device was discarded and is not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 21132 |
| MDR Report Key | 21132 |
| Date Received | 1994-07-28 |
| Date of Report | 1994-06-27 |
| Date of Event | 1994-06-14 |
| Date Facility Aware | 1994-06-14 |
| Report Date | 1994-06-27 |
| Date Reported to Mfgr | 1994-06-27 |
| Date Added to Maude | 1995-04-13 |
| 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 | 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 CUSTOM EPIDURAL ANESTHESIA TRAY |
| Generic Name | EPIDURAL ANESTHESIA CATHETER |
| Product Code | GZD |
| Date Received | 1994-07-28 |
| Model Number | NA |
| Catalog Number | S1550316 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 21106 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Manufacturer Address | 824 12TH AVE. BETHLEHEM PA 18018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-28 |