FDA Adverse Event
Malfunction
Summary report: N
10 - 20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
MDR report key: 8054676
·
Received November 9, 2018
Report
- Report Number
- 1066733-2018-00019
- Event Type
- Malfunction
- Date Received
- November 9, 2018
- Date of Event
- June 27, 2018
- Report Date
- November 8, 2018
- Manufacturer
- CHARTER MEDICAL, LTD.
- Product Code
- LPZ
- PMA / PMN Number
- BK1000049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT SAMPLE, OR PICTURES OF THE COMPLAINT DEVICE, WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/REVIEW. THE FAILURE MODE, OR POTENTIAL ROOT CAUSE FOR THE REPORTED INCOMPLETE SEAL IS UNKNOWN.
Description of Event or Problem · 1
CF-50 BAG LEAKED DURING PRODUCTION - THE CAUSE WAS DEFECTIVE MATERIAL FROM VENDOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 896277 | 10 - 20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER | 10 - 20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER | LPZ | CHARTER MEDICAL, LTD. | CF-50 | 152298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |