FDA Adverse Event
Malfunction
Summary report: N
COMBISET BLOODLINE
MDR report key: 2241312
·
Received August 22, 2011
Report
- Report Number
- 8030665-2011-00102
- Event Type
- Malfunction
- Date Received
- August 22, 2011
- Date of Event
- July 28, 2011
- Report Date
- August 22, 2011
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FJK
- PMA / PMN Number
- K962081
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A HEMODIALYSIS FACILITY HAS REPORTED THAT DURING TREATMENT A LEAK WAS NOTED ON THE VENOUS SIDE OF THE TUBING. THE LEAK APPEARED TO BE CAUSED BY PINHOLES IN THE TUBING. THE INCIDENT WAS CAUGHT IMMEDIATELY AND THE REPORTED BLOOD LOSS WAS MINIMAL, ESTIMATED AT 10CC'S. THE PATIENT HAD NO ILL EFFECT AND THE SAMPLE IS AVAILABLE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMBISET BLOODLINE | HEMODIALYSIS TUBING SET | FJK | REYNOSA MANUFACTURING | NA | 11CR01173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |