BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10743453 · Received October 27, 2020

    Report

    Report Number
    3003152976-2020-00474
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: ONE USED SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGE WAS OBSERVED IN THE SYRINGE THREADING. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2003211, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2003211 WERE USED FOR ADDITIONAL EVALUATION. NO DAMAGE OR MOLDING DEFECTS WAS OBSERVED ON ANY OF THE SYRINGES. TIP AND THREAD VERIFICATION TESTS ARE PERFORMED WITHIN THE MANUFACTURING ENVIRONMENT ACCORDING TO PROCEDURE. TESTING WAS PERFORMED ON THE RETURNED SAMPLE AS WELL AS THE TEN RETAINED SAMPLES AND FOUND ALL PRODUCT WAS WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE TIP SNAPPED OFF WHEN ATTACHED TO THE LINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LUER TIP OUTER CASING OF SYRINGE SNAPPED WHILST BEING ATTACHED TO A LINE. LUER TIP OUTER CASING SNAPPED WHEN ATTACHED TO THE LINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209512 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003211

    Patients

    Seq Age Sex Outcome Treatment
    1