BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFEDRAW BLOOD SUPPLY SYSTEM

    MDR report key: 8170896 · Received December 17, 2018

    Report

    Report Number
    8020616-2018-00093
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 4, 2018
    Manufacturer
    MERIT MEDICAL SINGAPORE PTE LTD.
    Product Code
    DSK
    PMA / PMN Number
    K885235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT RETURNING FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT THE DEVICE WAS PREPPED AND CONNECTED TO A NEONATE PATIENT. THE NURSE IDENTIFIED SALINE LEAKING FROM THE PRESSURE MONITORING SET JUST BEFORE THE PLANECTA FIVE MINUTES INTO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011235 SAFEDRAW BLOOD SUPPLY SYSTEM BLOOD SUPPLY SYSTEM DSK MERIT MEDICAL SINGAPORE PTE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening