MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-23 for EPIDURAL CATHETERIZATION KIT AK-05502 manufactured by Arrow International Inc..
[188215123]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[188215124]
Received via medwatch from fda# (b)(4). The complaint states that an epidural catheter was placed by anesthesia. Insertion was uncomplicated. Twelve hours later, nurse encountered difficulty upon attempt at catheter removal. Anesthesia called for assistance. Upon catheter removal; tip was not intact. Missing approximately 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 | 1036844-2020-00094 |
| MDR Report Key | 9866150 |
| Report Source | OTHER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-09-30 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-06-18 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 312 COMMERCE PLACE |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPIDURAL CATHETERIZATION KIT |
| Generic Name | ANESTHESIA CONDUCTION CATHETER |
| Product Code | BSO |
| Date Received | 2020-03-23 |
| Catalog Number | AK-05502 |
| Lot Number | 23F19F0158 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |