BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML E/T

    MDR report key: 10841543 · Received November 15, 2020

    Report

    Report Number
    3003152976-2020-00505
    Event Type
    Malfunction
    Date Received
    November 15, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903008668
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 11/3/2020. H.6. INVESTIGATION: ONE SAMPLE AND ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE PAPER OF THE BLISTER PACKAGE IS OBSERVED TO BE BROKEN. A DEVICE HISTORY REVIEW FOR LOT 1903323 WAS PERFORMED, FINDING ONE ANNOTATION RELATED TO THIS FAILURE. DURING THE PACKAGE PROCESS, AN INCIDENT WAS DETECTED IN THE PACKAGING MACHINE RELATED TO POOR PLACING OF THE BLISTERS INTO THE CARTON, WHICH COULD RESULT IN DAMAGED PACKAGING. ONCE DETECTED, THE FAILURE WAS REPAIRED. BASED ON OUR INVESTIGATION IT WAS DETERMINED THIS INCIDENT WAS LIKELY A RESULT OF THE FAILURE DETECTED DURING PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 60ML E/T HAD A DAMAGED PACKAGE WHICH COMPROMISED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PACKAGE BROKEN".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 60ML E/T HAD A DAMAGED PACKAGE, WHICH COMPROMISED STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PACKAGE BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306488 SYRINGE 60ML E/T PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300866 1903323 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1