FDA Adverse Event
Malfunction
Summary report: N
MINIBAG PLUS CONTAINER
MDR report key: 7053415
·
Received November 22, 2017
Report
- Report Number
- 1416980-2017-09285
- Event Type
- Malfunction
- Date Received
- November 22, 2017
- Report Date
- December 7, 2017
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- LXG
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COMMON DEVICE NAME: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
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 WERE ISSUES WITH A DAMAGED MINI-BAG DOCKING TOOL. THE DAMAGE WAS FURTHER DESCRIBED AS THE CLUTCH BEING STRIPPED AND THE VIAL SUPPORTS WOULD NOT LINE UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834086 | MINIBAG PLUS CONTAINER | SEE H10 | LXG | BAXTER HEALTHCARE - CLEVELAND | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |