FDA Adverse Event
Malfunction
Summary report: N
IVT DISPOSABLE
MDR report key: 3243990
·
Received July 24, 2013
Report
- Report Number
- 1416980-2013-19555
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Report Date
- June 28, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- KPE
- PMA / PMN Number
- K964853
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A 150 ML INTRAVIA CONTAINER HAD A CLEAR PLASTIC PARTICULATE MATTER INSIDE THE BAG. THIS EVENT WAS DISCOVERED AFTER THE BAG WAS FILLED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344798 | IVT DISPOSABLE | CONTAINER, I.V. | KPE | BAXTER HEALTHCARE - AIBONITO | UR13C07079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |