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 2020-02-12 for EPIDURAL CATHETERIZATION SET IPN046313 JC-05400-DCS manufactured by Arrow International Inc..
[180326416]
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
[180326417]
It was reported that the lor syringe is leaking water. The lot involved was mainly the lot# 71f19g1938 but we cannot provide the exact number of complaints with 71f19g1938 and lot# 71f19g2461 because the lot number is not on the syringe. 10 patients were involved and faced this incident. Clinical consequences: the epidural space is difficult to locate because of the lack of resistance. Out of the 10 patients involved there were one or two dura mater breach. So, no serious injury but few blood patches were applied with efficiency. Further information indicated that 5 patients had a blood patch procedure and those reports are filed as serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00131 |
| MDR Report Key | 9699826 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-02-12 |
| 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 | ANESTHESIA CONDUCTION KIT |
| Product Code | CAZ |
| Date Received | 2020-02-12 |
| Model Number | IPN046313 |
| Catalog Number | JC-05400-DCS |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-12 |