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..
[74592270]
(b)(4). The results of the investigation are pending at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[74592271]
It is reported that the patient's husband indicated that the catheter they used was cracked after insertion when they did dialysis (this event documented in mdr# 1036844-2017-00196). The hospital replaced the catheter, but the catheter was cracked again when the patient did dialysis.
Patient Sequence No: 1, Text Type: D, B5
[96519947]
(b)(4). The sample was not returned for evaluation. A device history record (dhr) review was performed on the catheter's extension lines and no relevant findings were identified. The instructions for use (ifu) warns that repeated over tightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure. It also states not to use acetone with this catheter and that the catheter, extension lines and connectors should be examined before and after each use. Complaint verification testing could not be performed because no sample was returned for analysis. A dhr review was performed and it did not reveal any manufacturing related issues. The probable cause of a leak in the connector assembly could not be determined based upon the information provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10
[96519948]
It is reported that the patient's husband indicated that the catheter they used was cracked after insertion when they did dialysis (this event documented in mdr# 1036844-2017-00196). The hospital replaced the catheter, but the catheter was cracked again when the patient did dialysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2017-00197 |
| MDR Report Key | 6549006 |
| 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 |