BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN ADMINISTRATON SET

    MDR report key: 2062801 · Received April 7, 2011

    Report

    Report Number
    1722139-2011-00060
    Event Type
    Other
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE 2 LOTS THAT WERE REPORTED IN THIS COMPLAINT (B)(4). LOT CF1022206 IS NOT A VALID LOT NUMBER. COMPLAINT RECORDS WERE REVIEWED FOR LOT D020235 AND NO OTHER COMPLAINTS FOR LEAKS HAVE BEEN RECEIVED IN THIS LOT. THE ACTUAL DEVICE HAS BEEN RECEIVED AND IS CURRENTLY BEING EVALUATED. A F/U WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE PT NOTICED THAT THE ADMINISTRATION SET WAS LEAKING FROM THE TUBE THAT RUNS FROM THE BAG TO THE PUMP. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATON SET FRN MOOG MEDICAL DEVICES GROUP 340-4128V D020235

    Patients

    Seq Age Sex Outcome Treatment
    1 CURLIN INFUSION PUMP