BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECELL TISSUE CULTURE FLASK

    MDR report key: 103128 · Received June 30, 1997

    Report

    Report Number
    6000004-1997-00020
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Date of Event
    June 2, 1997
    Report Date
    June 27, 1997
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KJA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECELL TISSUE CULTURE FLASK LIFECELL TISSUE CULTURE FLASK KJA BAXTER HEALTHCARE CORPORATION 4R2113 H96G18473

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN