FDA Adverse Event
Injury
Summary report: N
CARTRIDGE
MDR report key: 4297203
·
Received November 13, 2014
Report
- Report Number
- 8030638-2014-00012
- Event Type
- Injury
- Date Received
- November 13, 2014
- Manufacturer
- GAMBRO RENAL PRODUCTS S.A. DE C.V.
- Product Code
- FJK
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. A (B)(4) RETAINED BLOOD TUBING SAMPLES FROM THE SAME LOT NUMBER REPORTED (LOT# 1000083927) WERE VISUALLY INSPECTED, FUNCTIONAL AND LEAK TESTING WAS PERFORMED AND NO FAILURES OR DEFECTS WERE DETECTED. GAMBRO HAS NO INFO TO SUGGEST THAT BLOOD TUBING SET PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT AND GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.
Description of Event or Problem · 1
PLEASE REFER IMPORTER REPORT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734115 | CARTRIDGE | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | FJK | GAMBRO RENAL PRODUCTS S.A. DE C.V. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |