BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2890596 · Received November 21, 2012

    Report

    Report Number
    1722139-2012-01187
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO OBTAIN MORE INFO ABOUT PT INVOLVEMENT WITH NO RESPONSE. ONE (1) USED ADMINISTRATION SET WITH PART NUMBER 340-4128 WITHOUT OUTER BAG AND TWENTY SIX (26) BRAND NEW ADMINISTRATION SETS WERE RETURNED FOR EVAL. THE TWENTY SIX (26) ADMINISTRATION SETS WERE ALL CORRECTED ASSEMBLY (NO REVERSE). ONE (1) USED ADMINISTRATION SET WAS ASSEMBLY BACKWARD. COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT THE TUBING WITH PART NUMBER 340-4114 AND LOT # CF1201880 IS BACKWARD. THERE WAS NO INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1