FDA Adverse Event
Malfunction
Summary report: N
CRYOSTORE
MDR report key: 18707270
·
Received February 14, 2024
Report
- Report Number
- 1000160256-2024-00002
- Event Type
- Malfunction
- Date Received
- February 14, 2024
- Date of Event
- November 3, 2023
- Report Date
- February 14, 2024
- Manufacturer
- ORIGEN BIOMEDICAL, INC.
- Product Code
- KSR
- PMA / PMN Number
- BK030036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
CUSTOMER REPORTED THAT THE DRUG PRODUCT BAG FOR BATCH 23KC4031 HAD LEAKED DURING INFUSION OF THE DRUG PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809447 | CRYOSTORE | CRYOSTORE | KSR | ORIGEN BIOMEDICAL, INC. | CS50 | W22591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |