BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ LUER-LOK¿ BD HEMOGARD¿ TIP CAP BD ECLIPSE¿

    MDR report key: 7058858 · Received November 27, 2017

    Report

    Report Number
    9617032-2017-00204
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    January 20, 2016
    Report Date
    November 8, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT # 5251478 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE PLUNGER WHEN BD PRESET¿ LUER-LOK¿ BD HEMOGARD¿ TIP CAP 22G BD ECLIPSE¿ WAS IN VERTICAL POSITION DURING ACTION TO EJECT AIR BUBBLES FROM SYRINGE. NO BLOOD EXPOSURE TO MUCOUS MEMBRANE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840785 BD PRESET¿ LUER-LOK¿ BD HEMOGARD¿ TIP CAP BD ECLIPSE¿ SYRINGE JKA BECTON, DICKINSON AND COMPANY (BD) 5251478

    Patients

    Seq Age Sex Outcome Treatment
    1 Other