FDA Adverse Event
Malfunction
Summary report: N
PALL FREEZING BAG WITH 25 ML SEPARABLE
MDR report key: 1192924
·
Received October 10, 2008
Report
- Report Number
- 9617787-2008-00022
- Event Type
- Malfunction
- Date Received
- October 10, 2008
- Date of Event
- September 15, 2008
- Report Date
- October 8, 2008
- Manufacturer
- ENSATEC, S.A. DE C.V.
- Product Code
- KSR
- PMA / PMN Number
- BK980027
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
DURING THE PROCESSING OF (B) (6) FOR FROZEN STORAGE, THE LAB STAFF INTRODUCED THE UNIT INTO A BIOLOGIC FREEZER TO TAKE IT TO -120ºC. WHEN THEY TOOK THE UNIT OFF TO INTRODUCE IT INTO THE CRYOFREEZER THEY REALIZED THAT THE BAG WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALL FREEZING BAG WITH 25 ML SEPARABLE | PALL TANSFER/FREEZING BAG SET | KSR | ENSATEC, S.A. DE C.V. | 791-05U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |