BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ - 3-PIECE SYRINGE

    MDR report key: 17368321 · Received July 20, 2023

    Report

    Report Number
    3003152976-2023-00291
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    May 31, 2023
    Report Date
    July 8, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A PARTICLE IS OBSERVED WITHIN THE SYRINGE. WITHOUT A PHYSICAL SAMPLE WE COULD NOT CONDUCT CHARACTERIZATION ANALYSIS ON THE FOREIGN MATTER TO FURTHER IDENTIFY THE ORIGIN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2203146, 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. 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 FOUND. WITHOUT A PHYSICAL SAMPLE WE COULD NOT CONDUCT CHARACTERIZATION ANALYSIS ON THE FOREIGN MATTER TO FURTHER IDENTIFY THE ORIGIN. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS POSSIBLE THE PARTICLE GENERATED DURING THE ASSEMBLY PROCESS, GIVEN WE CANNOT IDENTIFY THE ORIGIN, WE CANNOT VERIFY THIS TO BE TRUE FOR THE INCIDENT REPORTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE HAD A FOREIGN BODY IN IT. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: VERBATIM: FOREIGN BODY WAS FOUND IN THE BOTTLED SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666565 BD PLASTIPAK ¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203146

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown