BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL

    MDR report key: 12125769 · Received July 6, 2021

    Report

    Report Number
    3003152976-2021-00365
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 REPORTED LOT 2103052, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL PACKAGE WAS DAMAGED. THIS OCCURRED ON 9600 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON DELIVERY, THE PACKAGES WERE BROKEN AND CRUSHED, THE PACKAGING COULD NO LONGER GUARANTEE THE STERILITY OF THE SYRINGES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL PACKAGE WAS DAMAGED. THIS OCCURRED ON 9600 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON DELIVERY, THE PACKAGES WERE BROKEN AND CRUSHED, THE PACKAGING COULD NO LONGER GUARANTEE THE STERILITY OF THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021187 SYRINGE 10ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2103052

    Patients

    Seq Age Sex Outcome Treatment
    1