BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEMIS 3000CC QUICK FIT SUCTION LINER

    MDR report key: 3072895 · Received March 25, 2013

    Report

    Report Number
    2133713-2013-00004
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER REPORTED THE FOLLOWING LOT NUMBERS HAD A FAILURE: 20120510, 20120713, 20120127.

    Description of Event or Problem · 1

    USER REPORTED FOUR SEPARATE INSTANCES OF 3000 CC SUCTION LINER LID CRACKING WHEN VACUUM WAS APPLIED IN THE LAST MONTH. THERE WAS NO INJURY REPORTED TO USER OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122828 BEMIS 3000CC QUICK FIT SUCTION LINER APPARATUS, VACUUM, SUCTION POWERED KDQ BEMIS MFG. CO. 3004 201212??

    Patients

    Seq Age Sex Outcome Treatment
    1