BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJCT 20ML SYR L-LOCK

    MDR report key: 14786390 · Received June 23, 2022

    Report

    Report Number
    1915484-2022-01280
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 31, 2022
    Report Date
    August 1, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMF
    UDI-DI
    10884521010802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. PIECES WERE VISUALLY INSPECTED AND PHYSICALLY TESTED WITH NO ISSUES FOUND. PRODUCT AND SPECIFICATION REQUIREMENTS WERE MET WITH NO NON-CONFORMING PRODUCT IDENTIFIED. FORTY-SEVEN SAMPLES, STILL IN THEIR SEALED BLISTER STRIPS WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION TO THE QUALITY INSPECTION STANDARD (QIS) WAS CONDUCTED. THE INSPECTION OF ALL THE SYRINGES FOUND NO DEVICES WITH A DAMAGED OR MISSING SYRINGE TIP. THE REPORTED CONDITION COULD NOT BE CONFIRMED. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED AT THIS TIME. THE MANUFACTURE OF ALL MOLDED COMPONENTS IS CONDUCTED WITHIN A VALIDATED PROCESS INSIDE A CONTROLLED MANUFACTURING AREA. THE CRITICAL DIMENSIONS OF THE MOLDED COMPONENTS ARE GAUGED TO ENSURE MOLDED COMPONENTS MEET DIMENSIONAL SPECIFICATIONS AND ARE VISUALLY AND PHYSICALLY TESTED FOR ADHERENCE TO THE QIS. IF PROBLEMS WERE DETECTED DURING PROCESSING, NON-CONFORMING PRODUCT WOULD BE IDENTIFIED AND SEGREGATED. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE INNER PIECE IS BREAKING OFF AT THE LUER-LOCK END. THE THREADS STAY BUT THE INNER STRAIGHT PIECE BREAKS OFF. THEY WERE LOSING COSTLY MEDICATIONS AT THE SAME TIME AND HAD TO DISPOSE OF THE WHOLE SYRINGE AND MEDICATION. PER ADDITIONAL INFORMATION RECEIVED ON 01JUN2022, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240787 MONOJCT 20ML SYR L-LOCK SYRINGE, PISTON FMF CARDINAL HEALTH 1182000777 122121X 10884521010802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown