MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CV-15122-FBZ manufactured by Arrow International Inc..
[133337476]
(b)(4). It is unknown if the device sample is available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[133337477]
Complaint description: "guidewire stuck and ruptured inside catheter during the procedure. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2019-00021 |
| MDR Report Key | 8252735 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-07 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2019-01-16 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V |
| Manufacturer Street | AVE. WASHINGTON 3701, EDIFICIO 4 COLONIA COMPLEJO INDUSTRIAL, LAS AMERICAS |
| Manufacturer City | CHIHUAHUA 31114 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM |
| Generic Name | CATHETER SUBCLAVIAN |
| Product Code | LFJ |
| Date Received | 2019-01-16 |
| Catalog Number | CV-15122-FBZ |
| Lot Number | 14F18D0014 |
| 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 | 2019-01-16 |