MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for PERFIX 17 GA, CLOSED TIP EPIDURAL NEEDLE CATHETER 332097 manufactured by B. Braun Medical, Inc..
[174671873]
Pt had an epidural placed for a c-section delivery. Delivery completed and nurse anesthetist removed the epidural catheter from the pt's spine. The taps and catheter were removed with minimal resistance. It was noted the epidural catheter tip was not fully intact after removal. A ct scan was done, metal catheter tip retained adjacent to right l2 lamina. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092123 |
| MDR Report Key | 9569553 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-05-26 |
| Date Added to Maude | 2020-01-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFIX 17 GA, CLOSED TIP EPIDURAL NEEDLE CATHETER |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-01-08 |
| Catalog Number | 332097 |
| Lot Number | 0061664554 |
| Device Expiration Date | 2020-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-08 |