BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML E/T

    MDR report key: 12425347 · Received September 3, 2021

    Report

    Report Number
    3003152976-2021-00557
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 5, 2021
    Report Date
    October 8, 2021
    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

    H6: INVESTIGATION SUMMARY PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION IT CAN BE OBSERVED THE PLUNGER IS NOT CORRECTLY ASSEMBLED TO THE PLUNGER. NO MOLDING OR OTHER DEFECTS HAVE BEEN NOTICED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2003208, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH A MISALIGNMENT OF PLUNGER-STOPPER-BARREL IN THE ASSEMBLY STATION. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE SYRINGE 60ML E/T THE STOPPER WAS DEFECTIVE/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE STOPPER IS DEFORMED."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE SYRINGE 60ML E/T THE STOPPER WAS DEFECTIVE/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE STOPPER IS DEFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318174 SYRINGE 60ML E/T PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300866 2003208 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1