BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCEAN CHEST DRAIN

    MDR report key: 2894397 · Received November 30, 2012

    Report

    Report Number
    1219977-2012-00029
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    August 15, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    PMA / PMN Number
    K043582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE PACKAGING PROCESS, INDICATED THAT THE PACKAGED DRAIN WAS PACKAGED AND INSPECTED ACCORDING TO SPECIFICATIONS AND THAT NO NON-CONFORMITIES WERE FOUND. DEVICE WAS NOT RETURNED, THEREFORE, AN EVALUATION WAS NOT PERFORMED AND NO CONCLUSION CAN BE DRAWN. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY RELEVANT ADDITIONAL INFORMATION THAT IS OBTAINED.

    Description of Event or Problem · 1

    AS THE OCEAN WATER SEAL CHEST DRAIN SYSTEM WAS OPENED, IT WAS DISCOVERED BY NURSING STAFF THAT THERE WERE HOLES IN THE BLUE WRAP ENCASING THE CHEST DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCEAN CHEST DRAIN KDQ ATRIUM MEDICAL CORPORATION 2002-000 10829133

    Patients

    Seq Age Sex Outcome Treatment
    1 Other