MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-10 for ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM CV-12122-F manufactured by Arrow International Inc..
[180127132]
Qn#: (b)(4). It is unknown if the device sample is available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[180127133]
The customer reports deformation and deterioration of the original dilator. Dilator frays at the end during insertion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00035 |
| MDR Report Key | 9577792 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-27 |
| Date of Event | 2019-12-14 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-02-14 |
| Date Added to Maude | 2020-01-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM |
| Generic Name | CATHETER, SUBCLAVIAN |
| Product Code | LFJ |
| Date Received | 2020-01-10 |
| Catalog Number | CV-12122-F |
| Lot Number | 71F19B1038 |
| 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 | 2020-01-10 |