FDA Adverse Event
Malfunction
Summary report: N
CRYOMACS FREEZING BAG 250
MDR report key: 6228881
·
Received January 6, 2017
Report
- Report Number
- 3005290010-2016-00102
- Event Type
- Malfunction
- Date Received
- January 6, 2017
- Date of Event
- November 30, 2016
- Report Date
- January 5, 2017
- Manufacturer
- MILTENYI BIOTEC GMBH
- Product Code
- LPZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A CAP OF CRYOMACS FREEZING BAG 250 SEEMED CROSS-THREADED AND WAS FOUND DURING THE PRE-PROCESS CHECK. NO PATIENT AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12103 | CRYOMACS FREEZING BAG 250 | CRYOMACS FREEZING BAG 250 | LPZ | MILTENYI BIOTEC GMBH | N/A | 6151202002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |