LIFECELL TISSUE CULTURE FLASK
Received Jun 30, 1997 · Event occurred Jun 2, 1997
Report 6000004-1997-00020 · MDR key 103128
Device
Generic name
Lifecell Tissue Culture Flask
Manufacturer
Baxter Healthcare CorporationModel number
4R2113Catalog number
4R2113
Lot number
H96G18473
Patient
UNKNOWN
Narrative
Description of Event or Problem
REPORTEDLY, A LIFECELL TISSUE CULTURE FLASK LEAKED WHILE IN THE INCUBATOR. THE CONTENTS LEAKED ONTO 5 OTHER CONTAINERS IN THE INCUBATOR. THE TECHNICIAN INDICATED THAT THE SEAL ON THE TUBING OF THE LIFECELL TISSUE CULTURE FLASK APPEARED TO BE INCOMPLETE. CELLCOR IS INVESTIGATING THE SEALER AS THE POTENTIAL PROBLEM. CELLS WERE LOST WHEN THE LEAKING CONTAINER AND THE 5 POSSIBLE CONTAMINATED CONTAINERS WERE DISCARDED, BUT SUFFICIENT PRODUCT REMAINED FOR THE PTS. THE PTS WERE NOT EFFECTED BY THIS EVENT. THE LEAKING CONTAINER HAS BEEN DISPOSED OF.