BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 21239979 · Received January 27, 2025

    Report

    Report Number
    1911916-2025-00046
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 10, 2025
    Report Date
    January 30, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010337
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP IT WAS REPORTED SOME SYRINGES ARE DEFECTIVE. TO AID IN THE INVESTIGATION, PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH THE SYRINGE LUER AND TIP DAMAGED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, POSSIBLE LOT NUMBERS 2125556, 2125579 AND 2152691. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE ASSEMBLY LINE WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    A CUSTOMER HAS REPORTED TO US THAT SOME SYRINGES ARE DEFECTIVE. PLEASE FIND ATTACHED PHOTOS AS PROOF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771742 SYRINGE 30ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 50382903010337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown