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 2017-12-27 for ARROW CANNON II PLUS REPLACEMENT HUB SET CAR-02400 manufactured by Arrow International Inc..
[96151790]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96151791]
The customer reports that a patient had a pemcath inserted 2 months ago, and a week ago presented with a cracked hub on one of the lumen, they changed the hub and inserted car02400, she has now returned with the hub leaking (documented in mdr# 1036844-2017-00456).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2017-00455 |
| MDR Report Key | 7148504 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-27 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2017-12-27 |
| 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 INTERNATIONAL INC. |
| Manufacturer Street | 312 COMMERCE PLACE |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW CANNON II PLUS REPLACEMENT HUB SET |
| Generic Name | KIT, REPAIR, CATHETER, HEMODI |
| Product Code | NFK |
| Date Received | 2017-12-27 |
| Catalog Number | CAR-02400 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| 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 | 2017-12-27 |