BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 15571818 · Received October 10, 2022

    Report

    Report Number
    3003152976-2022-00458
    Event Type
    Malfunction
    Date Received
    October 10, 2022
    Date of Event
    September 15, 2022
    Report Date
    November 16, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008667
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER E-MAIL: UNKNOWN. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?: YES. D10: RETURNED TO MANUFACTURER ON: 12-OCT-2022 H6: INVESTIGATION SUMMARY BOTH PHOTOS ALONG WITH THE PHYSICAL SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THOUGH VISUAL INSPECTION, DAMAGE IS OBSERVED IN THE BARREL OF THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2112007, 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. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, BASED ON THE DAMAGE OBSERVED, IT WAS DETERMINED THIS INCIDENT WAS LIKELY RELATED TO DAMAGE CAUSED DURING THE ASSEMBLY PROCESS, BY A TRIGGER IN THE SILICONE STATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ SYRINGES' BARRELS WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN BARREL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ SYRINGES' BARRELS WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN BARREL"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236928 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2112007 00382903008667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown