BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDEX SMALL BORE EXTENSION SET

    MDR report key: 3170438 · Received June 10, 2013

    Report

    Report Number
    2183502-2013-00307
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K841882
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    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

    IT WAS REPORTED THAT THE DEVICE WAS IN USE WITH A PATIENT WHEN THE LUMEN WITH AN ATTACHED BLUE CLAVE DEVELOPED A CRACK AND WAS OBSERVED TO BE LEAKING. THE PATIENT WAS FOUND TO HAVE LOW BLOOD SUGAR LEVELS AND WAS TREATED WITH A BOLUS OF GLUCOSE AFTER A NEW PIV WAS PLACED. NO FURTHER INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261407 MEDEX SMALL BORE EXTENSION SET FPA-INTRAVASCULAR ADMINISTRATIN SET FPA SMITHS MEDICAL MD, INC. NA 2401794

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention