BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 12345285 · Received August 19, 2021

    Report

    Report Number
    3003152976-2021-00483
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 7, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ZIP: (B)(6). INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT MANUFACTURING, INCLUDING VERIFICATION OF TIP DIMENSIONS. TESTING RESULTS PERFORMED DURING MANUFACTURING WERE REVIEWED AND ALL RESULTS WERE FOUND TO BE WITHIN REQUIRED LIMITS. TEN RETAINED SAMPLES OF LOT 2010081 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS OBSERVED ON ANY OF THE PRODUCT, INCLUDING THE SYRINGE TIPS. EVALUATIONS WERE PERFORMED, VERIFYING THE TIP WAS WITHIN REQUIRED SPECIFICATIONS WAS VERIFIED TO MEET REQUIRED SPECIFICATIONS, INCLUDING THE LUER CONE FITTING. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED TEN SYRINGE 1ML LS SP120 HAD NEEDLE CONNECTIVITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THERE ARE CASES WHERE THE CONNECTION WITH THE NEEDLE DOES NOT GO WELL AND IS EASY TO COME OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238621 SYRINGE 1ML LS SP120 PISTON SYRINGE FMI BECTON DICKINSON, S.A. 2010081

    Patients

    Seq Age Sex Outcome Treatment
    1