MalfunctionLPZ
PERMALIFE CELL CULTURE BAG
Received Dec 6, 2024 · Event occurred Aug 27, 2024
Report 1000160256-2024-00008 · MDR key 20870086
Device
Generic name
Permalife Cell Culture Bag, 120ml, With Scd Tubing
Manufacturer
Origen Biomedical, IncCatalog number
PL120N
Lot number
W23974
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS A PINHOLE THAT LED TO MATERIAL LEAKAGE FROM A PL120N CELL CULTURE BAG FOLLOWING REMOVAL OF THE BAG FROM INCUBATION. THIS LEAKAGE LED TO THE BATCH OF PRODUCT TO BE TERMINATED AND A SUBSEQUENT DELAY IN PATIENT TREATMENT GREATER THAN 24 HOURS.