MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for ARROW FLEXTIP PLUS EPIDURAL CATHETER IPN045607 AK-05502 manufactured by Teleflex Incorporated.
[180611199]
Epidural catheter placed by anesthesia. Insertion was uncomplicated. 12 hours later, nurse encountered difficulty upon attempt at catheter removal. Anesthesia called for assistance. Upon catheter removal, tip was not intact. Missing approx. 5cm of catheter tip. Patient required surgical exploration for catheter tip removal four days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9744493 |
| MDR Report Key | 9744493 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-09-19 |
| Report Date | 2020-02-17 |
| Date Reported to FDA | 2020-02-17 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Added to Maude | 2020-02-24 |
| 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 | ARROW FLEXTIP PLUS EPIDURAL CATHETER |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | CAZ |
| Date Received | 2020-02-24 |
| Model Number | IPN045607 |
| Catalog Number | AK-05502 |
| Lot Number | 23F19FO158 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD. MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |