FDA Adverse Event
Malfunction
Summary report: N
80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
MDR report key: 10058910
·
Received May 14, 2020
Report
- Report Number
- 1066733-2020-00008
- Event Type
- Malfunction
- Date Received
- May 14, 2020
- Date of Event
- April 15, 2020
- Report Date
- May 14, 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 SAMPLES WERE NOT RETURNED FOR INVESTIGATION. THERE WERE NO PICTURES OR OTHER INFORMATION PROVIDED, WHICH MAY HAVE INDICATED AN EXACT FAILURE MODE.
Description of Event or Problem · 1
THE END USER REPORTED SEAM BREAKS AT THE FILL PORT OF 3 DEVICES AFTER THE FREEZING. THERE WERE NO REPORTS OF SEAM BREAKS OR LEAKS UPON FILLING OR PRIOR TO FREEZING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518382 | 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER | 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER | LPZ | CHARTER MEDICAL, LTD. | CF-750 | 156377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |