BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 8939985 · Received August 28, 2019

    Report

    Report Number
    3003152976-2019-00587
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 12, 2019
    Report Date
    October 14, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 THE REPORTED LOT 1902237, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1902237 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS 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 2 SYRINGE 50ML LL EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 SEPERATE VERY SIMILLAR INCIDENTS WITHIN 24 HOURS. EVENT A: DRUG INSIDE SYRINGE LEAKS "BACKWARDS" THROUGH RUBBER SEAL.. EVENT B: WITHDRAWN DRUG ENDS UP BEHIND SILICON RUBBER AND ENDS UP BEHIND PLUNGER.

    Additional Manufacturer Narrative · 1

    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 2 SYRINGE 50ML LL EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 SEPARATE VERY SIMILAR INCIDENTS WITHIN 24 HOURS. EVENT A: DRUG INSIDE SYRINGE LEAKS "BACKWARDS" THROUGH RUBBER SEAL. EVENT B: WITHDRAWN DRUG ENDS UP BEHIND SILICON RUBBER AND ENDS UP BEHIND PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732573 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 1902237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other