BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS

    MDR report key: 5020738 · Received August 21, 2015

    Report

    Report Number
    5020738
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 14, 2015
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE HAD A FAILURE OF THE CATHETER TO SNUGGLY FIT AGAINST THE OBTURATOR, CAUSING THE BEVELED CUTTING EDGE TO NOT BE EXPOSED, CAUSING DIFFICULTY WITH ADVANCEMENT OF THE DEVICE INTO THE CHEST CAVITY. THE INITIAL ATTEMPT TO REACH THE FLUID WAS UNSUCCESSFUL, AS PRODUCT COULD ONLY BE ADVANCED ABOUT 1.5CM INTO THE SKIN. A SECOND KIT WAS OBTAINED AND VERIFIED THAT THE CATHETER FIT SNUGGLE AGAINST THE OBTURATOR, AND THE PROCEDURE WAS THEN DONE WITHOUT ANY IMMEDIATE COMPLICATIONS. FLUID WAS IMMEDIATELY REACHED, AND DRAINED IN THE USUAL FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553581 SAFE-T-CENTESIS NEEDLE, CATHETER GCB CAREFUSION 2200, INC. PIG1260T 0000791828

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR