FDA Adverse Event
Malfunction
Summary report: N
IVT DISPOSABLE
MDR report key: 3203671
·
Received July 3, 2013
Report
- Report Number
- 1416980-2013-17105
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Report Date
- June 10, 2013
- Manufacturer
- BAXTER HEALTHCARE - MALTA
- Product Code
- KPE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A 250 ML EVA BAG WAS OBSERVED TO HAVE A PARTICLE INSIDE THE PRIMARY BAG. THIS MALFUNCTION WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304509 | IVT DISPOSABLE | CONTAINER, I.V. | KPE | BAXTER HEALTHCARE - MALTA | 11J27V259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |