BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 10657199 · Received October 9, 2020

    Report

    Report Number
    3002682307-2020-00302
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 22, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: TWENTY SEALED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECTS WAS OBSERVED ON ANY OF THE PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2001218, NO DEVIATIONS OR NON-CONFORMANCE'S RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THROUGHOUT THE MANUFACTURING PROCESS, BREAK OUT FORCE, SUSTAINING FORCE TESTING AND SILICONE CONTENT TESTS ARE CONDUCTED FOR EACH LOT. TESTING RESULTS WERE REVIEWED FOR LOT 2001218 AND ALL RETURNED SAMPLES WERE EVALUATED AND FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 SYRINGES 50ML LL WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PK PUMPS OCCLUDING. 2 X PK PUMPS ALARMS SOUNDED DURING USE IN THEATRES. ALARMS READ "OCCLUSION". PROPOFOL TIVA WAS BEING ADMINISTERED. LINE WAS CHANGED WITH NO EFFECT. SYRINGE FROM THE SAME LOT NUMBER WAS CHANGED WITH NO EFFECT. PUMP WAS CHANGED WITH NO EFFECT. A FURTHER 6 PK PUMPS IN USE STARTED TO ALARM IN QUICK SUCCESSION ALL ALARMS READ "OCCLUSION". A 'DUMMY' PUMP WAS THEN SET UP WITH LINE & A SYRINGE FROM THE SAME LOT NUMBER & ALARM WAS REPLICATED. A NEW SYRINGE FROM A DIFFERENT LOT NUMBER WAS THEN TRAILED & NO FURTHER ALARMS WERE EXPERIENCED. THE AFFECTED LOT NUMBER WAS ISOLATED & NO FURTHER ALARMS WERE EXPERIENCED DURING THE THEATRE LIST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123996 SYRINGE 50ML LL PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2001218

    Patients

    Seq Age Sex Outcome Treatment
    1 Other