BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11586683 · Received March 29, 2021

    Report

    Report Number
    3003152976-2021-00174
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 3, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, A PARTICLE WAS OBSERVED INSIDE THE SYRINGE. AFTER FURTHER EVALUATION, THE FIBER WAS DETERMINED TO BE A POLYPROPYLENE FIBER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010060, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER USED TO REMOVE ANY POLYPROPYLENE PARTICLES INSIDE THE BARREL. 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. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE PARTICLES LIKELY GENERATED DURING THE MOLDING PROCESS DUE TO MOVEMENT OF THE PRODUCT WITHIN THE MANUFACTURING EQUIPMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUST PARTICLES/LINT IN THE SYRINGE. CUSTOMER WANTED TO PRODUCE MEDICINE WITH IT, IN THE PROCESS THE CONTAMINATION WAS NOTICED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUST PARTICLES/LINT IN THE SYRINGE. CUSTOMER WANTED TO PRODUCE MEDICINE WITH IT, IN THE PROCESS THE CONTAMINATION WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482040 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2010060

    Patients

    Seq Age Sex Outcome Treatment
    1