MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for PERIFIX 04046964178238 332215 manufactured by B. Braun Medical Inc..
[176979813]
Epidural catheter placed during labor; upon removal and not meet any resistance during removal, catheter portion found to be missing/retained after removal. Patient required to go to or from removal. Radiographic assessment indicates portion of catheter in l2-3 space. Sequestered intact catheter does not show stretched markings on catheter thus supports clinician's statement that no resistance was experienced during removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9647115 |
| MDR Report Key | 9647115 |
| Date Received | 2020-01-30 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-12-10 |
| Report Date | 2019-12-12 |
| Date Reported to FDA | 2019-12-12 |
| Date Reported to Mfgr | 2020-01-30 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| 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 | OGE |
| Date Received | 2020-01-30 |
| Model Number | 04046964178238 |
| Catalog Number | 332215 |
| 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 | 1. Hospitalization | 2020-01-30 |