BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2860004 · Received October 31, 2012

    Report

    Report Number
    1722139-2012-01107
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) UNUSED ADMINISTRATION SETS OF THE LISTED LOT NUMBER ABOVE WAS RETURNED FOR INVESTIGATION. A 100% INSPECTION WAS PERFORMED AND IDENTIFIED THAT (B)(4) ADMINISTRATION SETS CLEARLY HAD THE "BLACK SPEC" INSIDE THE FILTER. FILTER WAS MANUFACTURED BY FILTERTEK. THE (B)(4) ADMINISTRATION SETS WERE SENT TO FILTERTEK FOR INVESTIGATION. A FOLLOW UP WILL BE SENT WHEN NEW INFO IS RECEIVED FROM THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BLACK SPOTS INSIDE THE FILTER. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MED DEVICES GROUP 340-4128 CF1134392

    Patients

    Seq Age Sex Outcome Treatment
    1