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 2018-05-18 for ARROW CANNON II PLUS REPLACEMENT HUB SET CAR-02400 manufactured by Arrow International Inc..
[108726216]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[108726217]
The customer reports the catheter was found cracked and leaking which could not work during the dressing change by the nurse. This is the second occurrence. First occurrence documented in mdr #1036844-2018-00147.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2018-00148 |
| MDR Report Key | 7526810 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-18 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2016-10-13 |
| Date Added to Maude | 2018-05-18 |
| 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 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 | 2018-05-18 |
| Catalog Number | CAR-02400 |
| Lot Number | 23F16J0471 |
| Device Expiration Date | 2019-09-30 |
| 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 | 2018-05-18 |