MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for EPIDURAL CATHETERIZATION KIT AK-05502 manufactured by Arrow International Inc..
[183881821]
(b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[183881822]
It was reported that in placing a labor epidural, there was some difficulty due to patient movement and poor positioning. There was contact with bone, but the needle was redirected to find the epidural space. Nevertheless, there was a good loss of resistance (clear indication that the needle was in the epidural space), and medication was easily dosed through the needle. However, when i tried to pass the epidural catheter through the needle, the catheter movement was blocked and would not pass through the tip of the needle. After multiple attempts, i aborted the procedure and removed the needle, where i found that the bevel-tip was significantly bent, making it impossible for the plastic catheter to pass through. I had to start over again with a new needle/kit. Eventually, the 2nd kit allowed placement of the epidural catheter, but the delay of treatment caused additional pain for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2020-00085 |
| MDR Report Key | 9844946 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Returned To Mfg | 2020-02-25 |
| Catalog Number | AK-05502 |
| Lot Number | 23F19F0291 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |