BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX ADD-ON KIDS KIT BLOOD SAMPLING SYSTEM

    MDR report key: 1872191 · Received October 12, 2010

    Report

    Report Number
    2183502-2010-00454
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 11, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CBT
    PMA / PMN Number
    K070340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HAS BEEN RETURNED FOR EVAL. ONCE THE DEVICE HAS BEEN EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    THE RPTR STATED THAT A SYRINGE BECAME DISCONNECTED FROM THE FEMALE LUER OF THE DEVICE DURING USE. THERE WAS NO REPORTED PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEX ADD-ON KIDS KIT BLOOD SAMPLING SYSTEM CBT - ARTERIAL BLOOD SAMPLING KIT CBT SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK