BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 9141705 · Received October 1, 2019

    Report

    Report Number
    3003152976-2019-00681
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 16, 2019
    Report Date
    November 4, 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: FIVE UNUSED SAMPLES WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECT WAS OVERSERVED IN ANY OF THE PRODUCT THAT COULD HAVE RESULTED IN THE LEAK REPORTED, THE STOPPER NOTED TO BE PROPERLY ASSEMBLED IN ALL SAMPLES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1904224, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LEAKAGE TESTING WAS PERFORMED ON THE FIVE RETURNED SAMPLES, ALL PRODUCT MET SPECIFICATION AND NO LEAKS WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK SYRINGE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE ASSISTANTS, THE 50ML SYRINGE HAS LEAKED MORE OFTEN WITH THE LIQUID. 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. INFLIXIMAB WAS USED IN BOTH SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HAS BEEN REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK SYRINGE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE ASSISTANTS, THE 50ML SYRINGE HAS LEAKED MORE OFTEN WITH THE LIQUID. 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. INFLIXIMAB WAS USED IN BOTH SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937304 BD PLASTIPAK LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1904224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other