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 2020-02-11 for EPIDURAL CATHETERIZATION KIT NRFIT ASK-05500-NRON manufactured by Arrow International Inc..
[182720185]
(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
[182720186]
It was reported that the medical agent leaked from the filter during use on a patient. The user found the rotatable collar of the filter was broken, so that removed the catheter with the filter and snaplock adaptor and replaced with a new kit. According to the user, he/she had such experiences several times that when connecting the filter to snaplock adaptor, the rotatable collar got broken and detached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00172 |
| MDR Report Key | 9695778 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-02-11 |
| 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 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 NRFIT |
| Product Code | CAZ |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-02-25 |
| Catalog Number | ASK-05500-NRON |
| Lot Number | 71F19K1049 |
| 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 | 2020-02-11 |