MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-04-10 for 2-L HUB CONNECT ASSY REPLACEMENT SET CAR-02800 manufactured by Arrow International Inc.
[21109103]
It was reported in a general complaint that during therapies, they allege the clamps break very often. As a result they are exchanged. There have seen no pt deaths or complications reported. It is not known how many times this has occurred. It was noted they feel the material of the clamps is too hard compared to competitors' clamps.
Patient Sequence No: 1, Text Type: D, B5
[21304481]
(b)(4). F/u report will be filed if add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2013-00140 |
| MDR Report Key | 3061291 |
| Report Source | 01,07 |
| Date Received | 2013-04-10 |
| Date of Report | 2013-04-08 |
| Date of Event | 2013-02-01 |
| Date Mfgr Received | 2013-03-25 |
| Date Added to Maude | 2013-06-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 2400 BERNVILLE ROAD |
| Manufacturer City | READING PA 19605 |
| Manufacturer Country | US |
| Manufacturer Postal | 19605 |
| Manufacturer Phone | 6103780131 |
| Manufacturer G1 | ARROW INTERNATIONAL INC |
| Manufacturer Street | 312 COMMERCE PL. |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2-L HUB CONNECT ASSY REPLACEMENT SET |
| Generic Name | CHRONIC HEMODIALYSIS CATHETER PRODUCTS |
| Product Code | NFK |
| Date Received | 2013-04-10 |
| Catalog Number | CAR-02800 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC |
| Manufacturer Address | 2400 BERNVILLE ROAD READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-10 |