BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER ALL PURPOSE DRAINAGE CATHETER

    MDR report key: 1626339 · Received February 11, 2010

    Report

    Report Number
    1036710-2010-00005
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    January 25, 2010
    Report Date
    January 25, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    GBO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED COMPLAINT SAMPLE WAS VISUALLY EVALUATED AND IT WAS DETERMINED THAT THE POUCH DID NOT HAVE EVIDENCE OF A SEAL BEING FORMED. THE LACK OF ANY VISUAL ATTEMPT AT A SEAL INDICATES THAT THE POUCH DID NOT GO THROUGH THE MANUALLY OPERATED SEALING MACHINE, WHICH INDICATES THE LIKELY ROOT CAUSE AS EMPLOYEE ERROR. APPROPRIATE ACTION WAS TAKEN WITH THE EMPLOYEES DIRECTLY INVOLVED, AND A MEETING WAS HELD TO ADDRESS THE SEVERITY OF THE ISSUE. THERE WAS NO IN-HOUSE INVENTORY OF THE SUBJECT LOT IN STOCK TO CONDUCT A VISUAL EXAM AND NO ADDITIONAL COMPLAINTS OF OPEN SEALS HAVE BEEN RECEIVED FOR THE SUBJECT LOT.

    Description of Event or Problem · 1

    WHEN THE CUSTOMER PICKED UP THE CATHETER TO USE, THE CATHETER FELL RIGHT OUT OF THE PACKAGE. THERE WAS NO SEAL ON THE BOTTOM TO KEEP IT IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKATER ALL PURPOSE DRAINAGE CATHETER DRAINAGE CATHETER GBO ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 756510025 93411Y9M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other