BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL AMBER

    MDR report key: 11425351 · Received March 5, 2021

    Report

    Report Number
    3003152976-2021-00125
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    February 8, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES OF LOT 1912282 WHICH DISPLAY THE REPORTED CONDITION WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1912282 ,NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING THE MOLDING PROCESS, POLYPROPYLENE IS MIXED WITH COLORANT TO ACHIEVE THE PROPER AMBER COLORING OF THE SYRINGE. 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, NO ISSUES RELATED TO THIS INCIDENT WERE IDENTIFIED. ALTHOUGH NO DIRECT ISSUES WERE IDENTIFIED, THIS MALFUNCTION CAN OCCUR DUE TO IMPROPER COLORANT DOSING DURING THE MOLDING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL AMBER HAD FOREIGN MATTER INSIDE THE SYRINGE. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RED STREAKS IN THE PLASTIC OF THE SYRINGES.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 50ML LL AMBER HAD FOREIGN MATTER INSIDE THE SYRINGE. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RED STREAKS IN THE PLASTIC OF THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316215 SYRINGE 50ML LL AMBER SYRINGE FMF BECTON DICKINSON, S.A. 1912282

    Patients

    Seq Age Sex Outcome Treatment
    1