BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS DRY SUCTION CHEST DRAIN

    MDR report key: 2163513 · Received June 8, 2011

    Report

    Report Number
    1219977-2011-00002
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    PMA / PMN Number
    K950677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY SENT MEDWATCH REPORT TO FDA. ATRIUM FIRST LEARNED OF EVENT UPON RECEIPT OF REPORT FORWARDED TO ATRIUM FROM FDA. NO DEVICE RETURNED AND NOT LOT NUMBER PROVIDED. UNABLE TO REVIEW LOT HISTORY RECORD. REVIEWED COMPLAINT LOG FOR ANY SIMILARLY DESCRIBED EVENTS. NONE WERE NOTED. AN OASIS CHEST DRAIN DOES NOT HAVE A STOPCOCK, NOR DOES THE CONNECTOR TUBING OR THE THORACIC CATHETER. ATTEMPTED TO CONTACT THE HOSPITAL FOR FURTHER DETAILS. NO ADD'L DETAILS WERE FORTHCOMING. ATRIUM MEDICAL DISTRIBUTES MORE THAN (B)(4) CHEST DRAINS ANNUALLY AND HAS RECEIVED NO SIMILAR COMPLAINTS OF THIS TYPE.

    Description of Event or Problem · 1

    FROM USER FACILITY MEDWATCH REPORT: PT TRANSFERRED TO HAVE CHEST TUBE REPOSITIONED OR REPLACED AND THEY FOUND THAT THE STOPCOCK ON THE CATHETER WAS BROKEN AND WAS ALLOWING AIR TO FREELY GO IN AND OUT OF THE CHEST TUBE. UNSURE WHEN/HOW THIS HAPPENED. PT HAS HAD THE CHEST TUBE FOR 2 WEEKS. ORIGINAL INTENDED PROCEDURE: CHEST TUBE CLOSED SYSTEM (NOTE: THE ATRIUM OASIS CHEST DRAIN DOES NOT HAVE A STOPCOCK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASIS DRY SUCTION CHEST DRAIN KDQ BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORP. 3600-100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other