BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS

    MDR report key: 2142575 · Received June 20, 2011

    Report

    Report Number
    2183502-2011-00492
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 17, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.,
    Product Code
    KZL
    PMA / PMN Number
    BK860023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. EVALUATION SUMMARY: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    THERE WAS A REPORT OF AN OCCURRENCE OF THE FLUID WARMING INFUSION SET TUBING BECOMING KINKED. NO PATIENT INJURY OR ADVERSE EVENT 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 1972302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA