BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL 120/PKG

    MDR report key: 9913567 · Received April 1, 2020

    Report

    Report Number
    3002682307-2020-00118
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    March 12, 2020
    Report Date
    May 12, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY FIVE PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTOS, DAMAGE ON THE BARREL THREAD WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF LOT 1903236. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE 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, IT WAS DETERMINED THE DAMAGE WAS LIKELY CAUSED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 20ML LL 120/PKG EXPERIENCED THE TIP/LUER OF SYRINGE CRACKED/DAMAGED/DEFORMED/BENT. THE PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LOOKS TO ME AS IF IT COMES FROM THE ASSEMBLY PROCESS, WHERE THE PLUNGER IS PLACED IN THE CYLINDER. HOWEVER, IT DOES NOT LOOK LIKE AN INJECTION MOLDING PROCESS TO ME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 THAT AN UNSPECIFIED NUMBER OF SYRINGES 20ML LL 120/PKG EXPERIENCED THE TIP/LUER OF SYRINGE CRACKED/DAMAGED/DEFORMED/BENT. THE PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT LOOKS TO ME AS IF IT COMES FROM THE ASSEMBLY PROCESS, WHERE THE PLUNGER IS PLACED IN THE CYLINDER. HOWEVER, IT DOES NOT LOOK LIKE AN INJECTION MOLDING PROCESS TO ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372891 SYRINGE 20ML LL 120/PKG SYRINGE FMF BECTON DICKINSON, S.A. 1903236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other