BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL SYRINGE

    MDR report key: 17435581 · Received August 1, 2023

    Report

    Report Number
    3002682307-2023-00220
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 20, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THERE WAS NO OTHER DAMAGE OR DEFECTS THAT COULD BE IDENTIFIED WITHIN THE PHOTO THAT COULD HAVE CONTRIBUTED TO THE LEAK REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2211103, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING LEAKAGE TESTING. TEN RETAINED SAMPLES OF LOT 2211103 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPERS WERE VERIFIED TO BE PROPERLY ASSEMBLED ON TO THE PLUNGER ROD, AND NO LEAK WAS IDENTIFIED. BASED ON OUR INVESTIGATION, WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD CONVENTIONAL SYRINGE THE LIQUID LEAKED PAS THE PLUNGER. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: IT IS UNKNOWN HOW MANY SYRINGES ARE AFFECTED. WHEN DRAWING UP A DRUG TO BE GIVEN TO A PATIENT, WHEN THE SYRINGE IS TURNED UPSIDE DOWN, THE LIQUID LEAKS PAST THE PLUNGER DOWN THE HANDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD CONVENTIONAL SYRINGE THE LIQUID LEAKED PAST THE PLUNGER. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: IT IS UNKNOWN HOW MANY SYRINGES ARE AFFECTED. WHEN DRAWING UP A DRUG TO BE GIVEN TO A PATIENT, WHEN THE SYRINGE IS TURNED UPSIDE DOWN, THE LIQUID LEAKS PAST THE PLUNGER DOWN THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843645 BD CONVENTIONAL SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown