FDA Adverse Event
Malfunction
Summary report: N
30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
MDR report key: 10788595
·
Received November 4, 2020
Report
- Report Number
- 1066733-2020-00015
- Event Type
- Malfunction
- Date Received
- November 4, 2020
- Date of Event
- October 7, 2020
- Report Date
- November 4, 2020
- Manufacturer
- CHARTER MEDICAL, LTD.
- Product Code
- LPZ
- PMA / PMN Number
- BK100049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT SAMPLES WERE 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 LEAKS ARE UNKNOWN.
Description of Event or Problem · 1
THE USER FACILITY REPORTED A LEAK FROM THE TOP OF (3) CF-250 DEVICES NEAR THE FILL TUBE AND BAG WELD JUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1247845 | 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER | 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER, PRODUCT CODE: LPZ | LPZ | CHARTER MEDICAL, LTD. | CF-250 | 158373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |