BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX NEEDLE FREE PEDIATRIC 40" CLOSED BLOOD SAMPLE KIT

    MDR report key: 1850438 · Received September 21, 2010

    Report

    Report Number
    2183502-2010-00407
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 17, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CBT
    PMA / PMN Number
    K070340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS LOT WHICH WAS MANUFACTURED IN MARCH OF 2009. THE DEVICE HISTORY RECORDS INDICATE THAT THE LOT WAS FULLY INSPECTED AND NO ISSUES WERE NOTED; THE LOT PASSED PULL AND LEAK TESTING. THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. UPON EXAMINATION IT WAS CONFIRMED THAT THE TUBING HAD DISCONNECTED AT A SECTION WHERE IT HAD BEEN SOLVENT BONDED. THE BONDED AREA WAS VISUALLY EXAMINED, SOLVENT WAS PRESENT AT THE BONDED CONNECTIONS AND THE BONDING PROCESS APPEARED ACCEPTABLY PERFORMED. OUR EVALUATION WAS UNABLE TO DETERMINE ROOT CAUSE AND WE WERE UNABLE TO DETERMINE HOW OR WHEN THE DEVICE BECAME DISCONNECTED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DEVICE TUBING SEPARATED FROM THE FEMALE LUER LOCK. THERE WAS NO REPORTED PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEX NEEDLE FREE PEDIATRIC 40" CLOSED BLOOD SAMPLE KIT CLOSED BLOOD SAMPLING SYSTEMS CBT SMITHS MEDICAL ASD, INC. NA 1567768

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK