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 2020-02-05 for EPIDURAL CATHETERIZATION KIT TU-05500-J manufactured by Arrow International Inc..
[180321564]
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
[180321565]
It was reported that, after the snaplock leaked and the catheter was removed and replaced with a new kit, the snaplock leaked again. Therefore, the user again removed the catheter with snaplock adaptor and replaced with another new kit (the third one), by which no leak occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00158 |
| MDR Report Key | 9670788 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2019-07-25 |
| Date Added to Maude | 2020-02-05 |
| 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 KIT |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-03-17 |
| Catalog Number | TU-05500-J |
| Lot Number | 71F19G1342 |
| 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 | 2020-02-05 |