BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML E/T

    MDR report key: 10260976 · Received July 10, 2020

    Report

    Report Number
    3003152976-2020-00300
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 17, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903008668
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 2020-06-23. H.6. INVESTIGATION SUMMARY. ONE SAMPLE AND SEVERAL PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. AFTER VISUAL INSPECTION, THE THUMB PRESS OF THE PLUNGER IS OBSERVED TO BE BROKEN. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF LOT 1910286. THE AREAS WHERE PIECES RUN WITHIN THE MANUFACTURING EQUIPMENT 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. WE HAVE NOTIFIED MANUFACTURING PERSONNEL OF YOUR EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER. A PROJECT C-526-19 WAS INITIATED TO REDUCE ANY DAMAGE TO THE PRODUCT DURING MANUFACTURING. 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 THE SYRINGE 60ML E/T EXPERIENCED A BROKEN/DAMAGED PLUNGER ROD WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUSH CYLINDER BROKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE SYRINGE 60ML E/T EXPERIENCED A BROKEN/DAMAGED PLUNGER ROD WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUSH CYLINDER BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720200 SYRINGE 60ML E/T PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300866 1910286 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other