MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-05-05 for ARROW CANNON II PLUS REPLACEMENT HUB SET CAR-02400 manufactured by Arrow International Inc..
[74589013]
(b)(4). The results of the investigation are pending at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[74589014]
It is reported that the patient's husband indicated that the catheter they used was cracked after insertion when they did dialysis.
Patient Sequence No: 1, Text Type: D, B5
[96236315]
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review did not reveal any manufacturing related issues. Therefore, the probable cause for a crack in the luer hub could not be determined based upon the information provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10
[96236316]
It is reported that the patient's husband indicated that the catheter they used was cracked after insertion when they did dialysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2017-00196 |
| MDR Report Key | 6548808 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-05-05 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-06-21 |
| Device Manufacturer Date | 2014-06-24 |
| Date Added to Maude | 2017-05-05 |
| 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, HEMODIALYSIS |
| Product Code | NFK |
| Date Received | 2017-05-05 |
| Catalog Number | CAR-02400 |
| Lot Number | 23F14F1348 |
| Device Expiration Date | 2017-07-31 |
| Operator | LAY USER/PATIENT |
| 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 | 2017-05-05 |