BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL AMBER

    MDR report key: 21167265 · Received January 16, 2025

    Report

    Report Number
    3003152976-2025-00010
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    January 2, 2025
    Report Date
    February 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008698
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. TWO REPORTED LOT NUMBERS: BATCH: 2403080. BATCH CREATION DATE: 2024-03-04. BATCH EXPIRATION DATE: 2029-02-28. FULL UDI: (B)(4). BATCH: 2403499. BATCH CREATION DATE: 2024-03-04. BATCH EXPIRATION DATE: 2029-02-28. FULL UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    TWO SAMPLES AND FOUR PHOTOS ARE RECEIVED FROM THE CUSTOMER. THREE OF THE PHOTOS SHOW A SYRINGE AND POINT OUT THROUGH THE CYLINDER WHERE THE DEFECT WOULD BE. IN THE FOURTH PHOTO, THE IMAGE SHOWS A SYRINGE FROM ABOVE AND IT CAN BE SEEN THAT ONE OF THE PISTON ROD RINGS IS MISSING (FROM THE AREA WHERE THE STOPPER IS ASSEMBLED). THE SAMPLES ARE VISUALLY INSPECTED AND IN BOTH SAMPLE IT IS DETECTED THAT ONE OF THE QUADRANTS OF THE STEM RING (AREA WHERE THE STOPPER IS ASSEMBLED) IS BROKEN, A PIECE OF IT IS MISSING. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, NO DEFECTS OR ISSUES FOUND. DURING MANUFACTURING PROCESS BREAK OUT FORCE, SUSTAINING FORCE AND SILICONE CONTENT TESTS ARE PERFORMED, RESULTS FOR LOT 2403080 ARE WITHIN SPECIFICATION LIMITS. 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. POSSIBLE ROOT CAUSE IS RELATED WITH A HIT DURING TRANSPORT OR MANUFACTURING. DAMAGED PLUNGER CAN BE A RESULT DURING MANUFACTURING PROCESS. AREAS WHERE PIECES ARE TRANSPORTED IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    THERE IS A SEGMENT OF THE QUADRANT THAT IS BROKEN ON THE PLUNGER OF THE SYRINGE. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? PLEASE EXPLAIN DETAIL. NO HARM TO PATIENT/CAREGIVER AS THE DEFECT WAS FOUND DURING THE MANUFACTURING RELEASE STAGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509267 SYRINGE 50ML LL AMBER SYRINGE, PISTON FMF BECTON DICKINSON 2403499 00382903008698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown