BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEDRAW BLOOD SUPPLY SYSTEM

    MDR report key: 8170883 · Received December 17, 2018

    Report

    Report Number
    8020616-2018-00094
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 27, 2018
    Report Date
    November 28, 2018
    Manufacturer
    MERIT MEDICAL SINGAPORE PTE LTD.
    Product Code
    DSK
    PMA / PMN Number
    K885235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN PREPARATION FOR SUBMITTING 3500A FOLLOW UP INFORMATION, IT WAS DISCOVERED THAT THIS 3500A FILING FOR WAS A DUPLICATE OF THE 3500A [RGA NC-109525 MDR # 8020616-2018-00090] THAT WAS FILED ON 12-20-2018.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS RETURNED 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 PRESSURE MONITORING PROCEDURE, A LEAK WAS FOUND BETWEEN THE PLANECTA STOP COCK AND THE TUBING THAT CONNECTS TO THE PATIENT. THE SET WAS REPLACED. NO PATIENT INJURY TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010989 SAFEDRAW BLOOD SUPPLY SYSTEM BLOOD SUPPLY SYSTEM DSK MERIT MEDICAL SINGAPORE PTE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1