FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3130507
·
Received May 24, 2013
Report
- Report Number
- 1416980-2013-13404
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- February 22, 2013
- Report Date
- May 2, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FPA
- 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 THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS VISUALLY INSPECTED AND NO NONCONFORMANCES WERE OBSERVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CYSTO/BLADDER IRRIGATION SET PACKAGING RIPPED WHEN OPENING, COMPROMISING THE STERILITY OF THE PRODUCT. THIS WAS NOTICED BEFORE USE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232270 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE | R12K08189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |