BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEUR-EVAC

    MDR report key: 766725 · Received September 29, 2006

    Report

    Report Number
    3004365956-2006-00011
    Event Type
    Injury
    Date Received
    September 29, 2006
    Date of Event
    September 20, 2006
    Report Date
    September 28, 2006
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED FOR EVALUATION BUT IS NOT AVAILABLE. THE FACILITY STATED THEY ARE RETURNING AN UNUSED DEVICE FROM SAME LOT NUMBER FOR INVESTIGATION. SHOULD THE DEVICE BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED TO A TELEFLEX MEDICAL SALES REPRESENTATIVE, A CHEST TUBE DISCONNECTED FROM THE DEVICE UNIT. THIS CONDITION OCCURRED WHEN HOSPITAL STAFF "MILKED" CHEST TUBE AFTER SURGERY IN ICU. THE STAFF RECONNECTED DEVICE AT CONNECTOR SITE. A TIME LATER, THE PATIENT "CRASHED", WAS DEFIBRILLATED AND STABILIZED. THE DEVICE AGAIN BECAME DISCONNECTED DURING THIS EVENT AND RECONNECTED TO THE STABILIZED PATIENT. THE FACILITY IS NOT ALLEGING THAT THE DISCONNECT WAS RESPONSIBLE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR-EVAC SAHARA DUAL CHAMBER COLLECTION CONT FLO KDQ TELEFLEX MEDICAL NA 73092-1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R