BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMELINE LID

    MDR report key: 3695540 · Received March 19, 2014

    Report

    Report Number
    MW5035110
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    AESCULAP
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN THE LAST MONTH, WE HAVE HAD CRACKS DEVELOP IN 30 OF OUR AESCULAP PRIMELINE LIDS FOR OUR STERILCONTAINER SYSTEM RIGID STERILIZATION CONTAINERS. NONE OF THESE LIDS HAS BEEN PROCESSED MORE THAN 150 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162360 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162361 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162362 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162363 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162364 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162365 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162366 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162367 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162368 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162369 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162370 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162371 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162372 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162373 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162374 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162375 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162376 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162377 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162378 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162379 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162380 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162381 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162382 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162383 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162384 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162385 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162386 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162387 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162388 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12
    162394 PRIMELINE LID PRIMELINE LID KCT AESCULAP JP007 30-12

    Patients

    Seq Age Sex Outcome Treatment
    1