FDA Adverse Event
Malfunction
Summary report: N
30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
MDR report key: 10459310
·
Received August 27, 2020
Report
- Report Number
- 1066733-2020-00011
- Event Type
- Malfunction
- Date Received
- August 27, 2020
- Date of Event
- July 16, 2020
- Report Date
- August 27, 2020
- Manufacturer
- CHARTER MEDICAL, LTD.
- Product Code
- LPZ
- PMA / PMN Number
- BK100049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/REVIEW. A PICTURE PROVIDED BY THE REPORTER OF THIS COMPLAINT WAS INCONCLUSIVE. THE FAILURE MODE, OR POTENTIAL ROOT CAUSE FOR THE REPORTED LEAK IS UNKNOWN.
Description of Event or Problem · 1
BAG LEAK UNDER LABEL EDGE ON LEFT SIDE OF BAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 928124 | 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER | 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER | LPZ | CHARTER MEDICAL, LTD. | CF-250 | 154506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |