FDA Adverse Event
Malfunction
Summary report: N
IVT DISPOSABLE
MDR report key: 3200438
·
Received July 1, 2013
Report
- Report Number
- 1416980-2013-16969
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- June 6, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- KPE
- PMA / PMN Number
- K964853
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT 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. THE SAMPLE WAS DISCARDED BY THE CUSTOMER. THEREFORE, NO ANALYSIS CAN BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PORT TUBE OF AN INTRAVIA EMPTY CONTAINER HAD TORN OFF. THIS WAS DISCOVERED WHEN THE CUSTOMER WAS ATTEMPTING TO SPIKE THE BAG. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298833 | IVT DISPOSABLE | CONTAINER, I.V. | KPE | BAXTER HEALTHCARE - AIBONITO | UR13A18146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |