BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PERFUSION¿ SYRINGE W/NEEDLE

    MDR report key: 8550323 · Received April 25, 2019

    Report

    Report Number
    3003152976-2019-00288
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 20, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE USED SAMPLE WAS PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. WHILE INSPECTING THE PRODUCT, A LEAKAGE WAS OBSERVED BETWEEN THE STOPPER RIBS. NO DAMAGE OR MOLDING DEFECT WAS IDENTIFIED THAT COULD CONTRIBUTE TO THE LEAK AND THE STOPPER WAS NOTED TO BE PROPERLY ASSEMBLED TO THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1812216, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1812216 WERE USED TO CONDUCT A LEAKAGE TEST. PRODUCT WAS DISASSEMBLED AND INSPECTED, NO DEFECTS OR DAMAGE WERE NOTED, AND NO LEAK WAS 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 WAS REPORTED THAT DURING USE OF THE BD PERFUSION¿ SYRINGE W/NEEDLE THE MEDICINE LEAKS THROUGH THE PLUNGER AND BEHIND IT. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: WHEN DRAWING THE MEDICINE FIRST TIME ALREADY NOT TIGHT. THE LIQUID GOES INTO THE PLUNGER OF THE SYRINGE AND BEHIND IT.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT DURING USE OF THE BD PERFUSION¿ SYRINGE W/NEEDLE THE MEDICINE LEAKS THROUGH THE PLUNGER AND BEHIND IT. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN DRAWING THE MEDICINE FIRST TIME ALREADY NOT TIGHT. THE LIQUID GOES INTO THE PLUNGER OF THE SYRINGE AND BEHIND IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344197 BD PERFUSION¿ SYRINGE W/NEEDLE SYRINGE WITH NEEEDLE FMI BECTON DICKINSON, S.A. 1812216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other