BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 8992167 · Received September 11, 2019

    Report

    Report Number
    3003152976-2019-00615
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 26, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE 50ML LL SYRINGE OF LOT: 1904224 WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PRODUCT, A LEAKAGE BETWEEN THE STOPPER RIBS WAS OBSERVED. THERE WAS NO DAMAGE OR MOLDING DEFECTS NOTED ON ANY COMPONENTS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT: 1904224, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS RELATED TO THIS MALFUNCTION. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID RUNS INTO THE COMPARTMENT JUST BELOW THE BLACK STOPPER OF THE SYRINGE AND COLLECTS THERE. SOMETIMES IT ALSO GOES DOWN AND THE SYRINGE STARTS TO LEAK. SO IT'S MORE COMMON ACCORDING TO OUR ASSISTANTS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID RUNS INTO THE COMPARTMENT JUST BELOW THE BLACK STOPPER OF THE SYRINGE AND COLLECTS THERE. SOMETIMES IT ALSO GOES DOWN AND THE SYRINGE STARTS TO LEAK. SO IT'S MORE COMMON ACCORDING TO OUR ASSISTANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794385 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1904224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other