MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for TELEFLEX ARROW FLEXTIP PLUS EPIDURAL CATHETER SJ-05501 IPN046629 manufactured by Arrow International, Inc. (subsidiary Of Teleflex).
[176460253]
The pt had a teleflex arrow epidural catheter for pain control r/t a total knee arthroplasty. Upon removal of the catheter, despite no resistance, the catheter was not intact once removed. The plastic sheath on the tip of the catheter was broken off approx 2cm from the end. The metal wire within the catheter was not frayed or broken. Evidence of epidural fragment retained left lateral and posterior aspects of l3 vertebral body with portion extending through right aspect l2-3 intralumbar space. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092444 |
| MDR Report Key | 9622242 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-21 |
| Date Added to Maude | 2020-01-23 |
| 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 | 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 | TELEFLEX ARROW FLEXTIP PLUS EPIDURAL CATHETER |
| Generic Name | ANESTHESIA, CONDUCTION KIT |
| Product Code | CAZ |
| Date Received | 2020-01-22 |
| Model Number | SJ-05501 |
| Catalog Number | IPN046629 |
| Lot Number | 23F19J0362 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX) |
| Manufacturer Address | READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |