BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 3100081 · Received April 29, 2013

    Report

    Report Number
    1722139-2013-00437
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1401-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) USED ADMINISTRATION SETS WERE RETURNED TO (B)(4) MOOG FOR INVESTIGATION. THEY WERE TESTED UNDER 18 PSI AND (B)(4) WERE LEAKED. REFERENCE RECALL NUMBER Z-1401-2012.

    Description of Event or Problem · 1

    INFO REC'D INDICATES THAT THE SETS WERE LEAKING AT THE CONNECTION WITH THE CAREFUSION MP 1000 NEEDLELESS ACCESS DEVICE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184766 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4114 CF1125118

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NAFACILLIN 2 GMS