BEUDAMED
    FDA Adverse Event Summary report: N

    CHILDREN'S MEDICAL VENTURES

    MDR report key: 1082827 · Received July 17, 2008

    Report

    Report Number
    1082827
    Date Received
    July 17, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CHILDREN'S MEDICAL VENTURES, INC.
    Product Code
    KYX
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    RN GETTING READY TO USE A RESPIRONICS CHILREN'S MEDICAL VENTURES 60ML ORAL SYRINGE FOUND THE PACKAGING TO CONTAIN WOOD SPLINTERS INSIDE THE PLUNGER AND WITHIN PACKAGING. ALL SYRINGES FROM THAT LOT# WERE PULLED FROM THE UNIT.====================== MANUFACTURER RESPONSE FOR 60 ML ORAL SYRINGE, CHILDREN'S MEDICAL VENTURES======================MANUFACTURER PROVIDED RGA# FOR RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILDREN'S MEDICAL VENTURES SYRINGE, ORAL KYX CHILDREN'S MEDICAL VENTURES, INC. 1047084 54177

    Patients

    Seq Age Sex Outcome Treatment
    1 *