FDA Adverse Event
Malfunction
Summary report: N
IVT DISPOSABLE
MDR report key: 3223252
·
Received July 12, 2013
Report
- Report Number
- 1416980-2013-18158
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Report Date
- June 17, 2013
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- KPE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.
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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN 1000ML EVACUATED CONTAINER HAD A PUNCTURED STOPPER. THIS WAS DISCOVERED 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 |
|---|---|---|---|---|---|---|---|
| 321921 | IVT DISPOSABLE | CONTAINER, I.V. | KPE | BAXTER HEALTHCARE - CLEVELAND | G107367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |