MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-17 for EPIDURAL CATHETERIZATION SET IPN046316 JC-05400-LL2 manufactured by Arrow International Inc..
[180328320]
Qn#: (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
[180328321]
It was reported that the plunger of the syringe in the barrel is leaking. It is a liquid leak. The device was replaced by one from another supplier. Further information indicates that there was no patient injury. No medical intervention. It is already a difficult action to perform and to know if the anesthetist is in the epidural space because the syringe is leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00189 |
| MDR Report Key | 9716521 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2020-02-17 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | ARROW INTERNATIONAL CR, A.S. |
| Manufacturer Street | JAMSKA 2359/47 |
| Manufacturer City | ZDAR NAD SAZAVOU 591 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 591 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPIDURAL CATHETERIZATION SET |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-02-17 |
| Returned To Mfg | 2020-02-26 |
| Model Number | IPN046316 |
| Catalog Number | JC-05400-LL2 |
| Lot Number | 71F19G1101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-17 |