MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-09 for PERIFIX 332098 manufactured by B. Braun Medical, Inc..
[113418235]
Epidural catheter would not flush, x2 kits used with same problem both times, connector would not flush.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7669304 |
| MDR Report Key | 7669304 |
| Date Received | 2018-07-09 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-06-24 |
| Report Date | 2018-06-29 |
| Date Reported to FDA | 2018-06-29 |
| Date Reported to Mfgr | 2018-07-09 |
| Date Added to Maude | 2018-07-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | PERIFIX |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2018-07-09 |
| Model Number | 332098 |
| Catalog Number | 332098 |
| Lot Number | 0061604114 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-07-09 |