BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML14GA 1-1/4IN PERFUSION

    MDR report key: 10117369 · Received June 3, 2020

    Report

    Report Number
    3002682307-2020-00179
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 4, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1912207, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED. NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN ANY OF THEM THAT COULD CAUSE LEAKAGE. THE STOPPER IS CORRECTLY ASSEMBLED TO THE PLUNGER IN THE TEN SAMPLES. LEAKAGE TESTING WAS PERFORMED, THEY ARE DISASSEMBLED NOT OBSERVING ANY DAMAGE IN PLUNGER ROD THAT COULD HAVE CAUSED LEAKAGE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML14GA 1-1/4IN PERFUSION LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER FILLING THE SYRINGE, THE LIQUID HAS RUN OUT BACKWARDS FROM THE PLUNGER."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML14GA 1-1/4IN PERFUSION LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER FILLING THE SYRINGE, THE LIQUID HAS RUN OUT BACKWARDS FROM THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581164 SYRINGE 50ML14GA 1-1/4IN PERFUSION SYRINGE FMF BECTON DICKINSON, S.A. 1912207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other