BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFEDRAW BLOOD SUPPLY SYSTEM

    MDR report key: 8190095 · Received December 21, 2018

    Report

    Report Number
    8020616-2018-00091
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    December 14, 2018
    Report Date
    December 14, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGES THAT DURING A HEMODYNAMIC PRESSURE MONITORING PROCEDURE WITHIN THE NEWBORN INTENSIVE CARE UNIT [NICU], BLOOD WAS FOUND LEAKING FROM THE PLACENTA ON THE PRESSURE MONITORING SET. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030513 SAFEDRAW BLOOD SUPPLY SYSTEM BLOOD SUPPLY SYSTEM DSK MERIT MEDICAL SINGAPORE PTE LTD. C1356250

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening