BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX TRANSTAR KIDSKIT 45CM CLOSED BLOOD SAMPLE KIT

    MDR report key: 2123549 · Received June 9, 2011

    Report

    Report Number
    2183502-2011-00475
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Report Date
    June 8, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    CBT
    PMA / PMN Number
    K070340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE, AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DEVICE TUBING SEPARATED. 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 TRANSTAR KIDSKIT 45CM CLOSED BLOOD SAMPLE KIT CLOSED BLOOD SAMPLING SYSTEMS CBT SMITHS MEDICAL INTERNATIONAL LTD. NA 1365427

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK