FDA Adverse Event
Malfunction
Summary report: N
2-L HUB CONNECT ASSY REPLACEMENT SET
MDR report key: 3050261
·
Received April 5, 2013
Report
- Report Number
- 1036844-2013-00127
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- February 1, 2013
- Report Date
- April 4, 2013
- Manufacturer
- ARROW INTL., INC.
- Product Code
- NFK
- PMA / PMN Number
- K020430
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
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 BEEN NO PATIENT 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139834 | 2-L HUB CONNECT ASSY REPLACEMENT SET | CHRONIC HEMODIALYSIS CATHETER PRODUCTS | NFK | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |