MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for ARROW IPN034268 ASK-04020-MHS manufactured by Teleflex Medical.
[184851568]
From staff: while placing the arterial line in the radial artery, the catheter broke, separating the needle from the kit. Physician was able to remove needle from the field before advancing it into patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9877382 |
| MDR Report Key | 9877382 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-10 |
| Report Date | 2020-03-12 |
| Date Reported to FDA | 2020-03-12 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW |
| Generic Name | WIRE, GUIDE, CATHETER |
| Product Code | DQX |
| Date Received | 2020-03-25 |
| Model Number | IPN034268 |
| Catalog Number | ASK-04020-MHS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |