BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ - 3-PIECE SYRINGE

    MDR report key: 16981269 · Received May 22, 2023

    Report

    Report Number
    3003152976-2023-00193
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 27, 2023
    Report Date
    June 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, IT CAN BE OBSERVED TWO STRIPS JOINED BY THE SHORT EDGE, AND EMPTY PACKAGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2202063, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE TEAMS INVESTIGATION, POSSIBLE ROOT CAUSE IS ASSOCIATED WITH MALADJUSTMENT IN THE CROSSCUT OF BLISTERS, IF STRIPS OF UNITARY PACKAGING ARE NOT CORRECTLY SEPARATED, AN EMPTY STRIP IS NOT CORRECTLY DISCARDED AND THEREFORE, IT CAN BE PACKAGED IN THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO BREAKAGE GROOVE IN THE PACKAGED SYRINGES AND THE SECOND PACKAGING PART IS ALWAYS EMPTY(SECOND SYRINGE MISSING). MEANS THERE ARE MUCH LESS SYRINGES IN THE TOTAL PACKAGE THAN THE TOTAL PACKAGE DESCRIBES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS NO BREAKAGE GROOVE IN THE PACKAGED SYRINGES AND THE SECOND PACKAGING PART IS ALWAYS EMPTY(SECOND SYRINGE MISSING). MEANS THERE ARE MUCH LESS SYRINGES IN THE TOTAL PACKAGE THAN THE TOTAL PACKAGE DESCRIBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849084 BD PLASTIPAK ¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202063

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown