BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS

    MDR report key: 2030348 · Received March 21, 2011

    Report

    Report Number
    2183502-2011-00088
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    FLUID WARMING INFUSION SETS REPORTED A LEAK AT THE GAS VENT. NO PT INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS KZL - DISPOSABLE IV FLUID WARMING SET KZL SMITHS MEDICAL ASD, INC. NA 1792659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA