FDA Adverse Event
Malfunction
Summary report: N
INTRAVIA CONTAINER EMPTY
MDR report key: 6206582
·
Received December 27, 2016
Report
- Report Number
- 1416980-2016-18777
- Event Type
- Malfunction
- Date Received
- December 27, 2016
- Date of Event
- June 30, 2016
- Report Date
- December 27, 2016
- Manufacturer
- BAXTER HEALTHCARE - DOMINICAN REPUBLIC
- 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
THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LEAK FROM THE SEAM OF A 250ML INTRAVIA CONTAINER. THIS WAS DISCOVERED AFTER FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 856737 | INTRAVIA CONTAINER EMPTY | CONTAINER, I.V. | KPE | BAXTER HEALTHCARE - DOMINICAN REPUBLIC | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |