BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE, 50 ML W/LBL PKT.

    MDR report key: 1418657 · Received April 1, 2009

    Report

    Report Number
    1416980-2009-00016
    Event Type
    Malfunction
    Date Received
    April 1, 2009
    Date of Event
    March 4, 2009
    Report Date
    April 1, 2009
    Manufacturer
    BAXTER HEALTHCARE- MOUNTAIN HOME
    Product Code
    KSR
    PMA / PMN Number
    BK950049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ASSESSMENT OF THE CASE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON ITS COMPLETION.

    Description of Event or Problem · 1

    THIS IS A REPORT RECEIVED BY BAXTER (B)(4) ON (B)(6) 2009, FROM A CUSTOMER. ON (B)(6) 2009, THE CUSTOMER OBSERVED THAT ONE UNIT OF CRYOCYTE, 50 ML W/LBL PKT. (CODE R4R9951, BATCH H08C24097) SHOWED A CRACK NEAR THE SEAL DURING THAWING. BEFORE THAWING, NOTHING WAS OBSERVED. THE CUSTOMER PUT 7 ML IN THIS BAG. NO CLINICAL IMPACT ON THE PT AND/OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE, 50 ML W/LBL PKT. 81KSR KSR BAXTER HEALTHCARE- MOUNTAIN HOME H08C24097

    Patients

    Seq Age Sex Outcome Treatment
    1