MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for DESIGN OPTIONS? PERIFIX FX EPIDURAL ANESTESIA TRAY 555296 manufactured by B. Braun Medical Inc..
[184844503]
Patient experiencing return of pain and pressure. Rn found epidural catheter had become disconnected. The clip at the end of the yellow filter became unclipped from the epidural catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9877554 |
| MDR Report Key | 9877554 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-17 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| 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 | 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 | DESIGN OPTIONS? PERIFIX FX EPIDURAL ANESTESIA TRAY |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-03-25 |
| Model Number | 555296 |
| Catalog Number | 555296 |
| Lot Number | 006168312 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |