BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 18752177 · Received February 21, 2024

    Report

    Report Number
    3003152976-2024-00090
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    February 8, 2024
    Report Date
    June 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - FOLLOW UP MDR FOR ADDITIONAL INFORMATION AND DEVICE EVALUATION PLUNGER ROD BROKEN: ADDITIONAL INFORMATION: FOLLOWING SUBMISSION OF INITIAL MDR, LOT CODE WAS CLARIFIED BASED ON SAMPLES RETURNED AND UPDATED FROM UNKNOWN TO (B)(6) IN SECTION D. TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE THUMBPRESS OF THE PLUNGER RODS ARE OBSERVED TO BE DAMAGED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF LOT 2201026. THREE RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCTS WERE INSPECTED, NO DAMAGE WAS FOUND TO ANY OF THE PLUNGER RODS. 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, NO ISSUES RELATED TO THE REPORTED INCIDENT WAS IDENTIFIED. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THE DAMAGE OBSERVED ON THE PLUNGER ROD WAS LIKELY CAUSED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    NUMEROUS SYRINGES HAVE DAMAGE TO THE PLUNGER.

    Description of Event or Problem · 0

    NUMEROUS SYRINGES HAVE DAMAGE TO THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62344 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2201026 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown