MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-01-29 for 2-L HUB CONNECT ASSY REPLACEMENT SET CAR-02800 manufactured by Arrow Intl., Inc..
[3383278]
It was reported the procedure was being performed in the dialysis department. The blue and red pinch clamps are breaking easily. As a result, a new repair kit was used to correct the issue. The connectors were mat(dull finish) before and are now brilliant (shiny finish).
Patient Sequence No: 1, Text Type: D, B5
[10547483]
(b)(4). Follow up report will be filed if add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1036844-2013-00038 |
MDR Report Key | 3005968 |
Report Source | 01,07 |
Date Received | 2013-01-29 |
Date of Report | 2013-01-28 |
Date of Event | 2012-01-01 |
Date Mfgr Received | 2013-01-15 |
Device Manufacturer Date | 2009-09-01 |
Date Added to Maude | 2013-04-16 |
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 RD |
Manufacturer City | READING PA 19605 |
Manufacturer Country | US |
Manufacturer Postal | 19605 |
Manufacturer Phone | 6103780131 |
Manufacturer G1 | ARROW INTL., INC. |
Manufacturer Street | 312 COMMERCE PL. |
Manufacturer City | ASHEBORO NC 27203 |
Manufacturer Country | US |
Manufacturer Postal Code | 27203 |
Single Use | 3 |
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 | 2013-01-29 |
Catalog Number | CAR-02800 |
Lot Number | RF9096856 |
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 INTL., INC. |
Manufacturer Address | 2400 BERNVILLE RD READING PA 19805 US 19805 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-01-29 |