BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BNS

    MDR report key: 19561246 · Received June 18, 2024

    Report

    Report Number
    1911916-2024-00436
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 28, 2024
    Report Date
    May 31, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010351
    PMA / PMN Number
    K110771
    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 FOR DEVICE EVALUATION. IT WAS REPORTED THERE WERE CRACKS UNDER THE PLUNGER STEM. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS NO PACKAGING BLISTER, AND FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE PLUNGER ROD HAS A DISC AT 5 1/4" FROM THE TOP. THE DISC IS AN ACCEPTABLE IMPERFECTION FROM THE MOLDING PROCESS. THE FOUR PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035, LOTS 2243893, 2278572, 2278567 AND 2126481. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED BUT CONSIDERED AN ACCEPTABLE IMPERFECTION. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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

    I WOULD LIKE TO RAISE A SUPPLIER COMPLAINT REGARDING DEFECTIVE 30ML AND 50ML SYRINGES. OUR CUSTOMER HAS REJECTED SYRINGES DUE TO CRACKS UNDER THE PLUNGER STEM. PLEASE FIND THE SUMMARY BELOW AND PHOTOS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937561 SYRINGE 50ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 2126481 50382903010351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown