BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 9174877 · Received October 10, 2019

    Report

    Report Number
    3003152976-2019-00710
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 23, 2019
    Report Date
    November 14, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SEALED SAMPLE OF 50LL LOT 1905216 WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE SAMPLE, NO DAMAGE WAS NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK AND NO LEAKAGE WAS OBSERVED. TEN RETAINED SAMPLES OF 50LL LOT 1905240 WERE EVALUATED. ON VISUAL INSPECTION OF THESE TEN SAMPLES, NO DAMAGE OR MOLDING DEFECTS CAN BE OBSERVED AND THE STOPPER IS CORRECTLY ASSEMBLED. A LEAK TEST WAS ALSO PERFORMED ON THE TEN RETAINED SAMPLES WHICH MET SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THE REPORTED LOTS. BASED UPON THE VISUAL INSPECTION OF THE RETAINED SAMPLES, THE SAMPLE RECEIVED AND THE QUALITY TEAM'S INVESTIGATION, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIQUID RUNS OUT ON THE SYRINGE PLUNGER.

    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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIQUID RUNS OUT ON THE SYRINGE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968344 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1905216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other