MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-05 for 2-L HUB CONNECT ASSY REPLACEMENT SET CAR-02800 manufactured by Arrow International Inc.
[15155628]
It was reported that in dialysis, the extension lines of the replacement kit were leaking hindering the normal dialysis procedure. As a result, the staff replaced the extension lines with a repair kit an it was used w/o issue. It is not known if this issue cause a delay, however, no death or complications were reported as a result of this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[15283724]
(b)(4). F/u report will be filed if add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2013-00194 |
| MDR Report Key | 3159348 |
| Report Source | 01,07 |
| Date Received | 2013-06-05 |
| Date of Report | 2013-06-04 |
| Date of Event | 2013-05-15 |
| Date Mfgr Received | 2013-05-16 |
| Date Added to Maude | 2013-08-26 |
| 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 PLACE |
| 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 | 2013-06-05 |
| Returned To Mfg | 2013-05-28 |
| 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 | 2013-06-05 |