MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for PERFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY 332220 manufactured by B. Braun Medical, Inc..
[180179621]
Connector piece would not hold epidural catheter, crna attempted to insert catheter three times and each time catheter would slip out of the connector. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093052 |
| MDR Report Key | 9728407 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-13 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 CONTINUOUS EPIDURAL ANESTHESIA TRAY |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | CAZ |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-02-14 |
| Catalog Number | 332220 |
| Lot Number | 0061665815 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-02-18 |