BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 20492938 · Received October 21, 2024

    Report

    Report Number
    1911916-2024-00742
    Event Type
    Malfunction
    Date Received
    October 21, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010313
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. ADDITIONAL BATCH REPORTED: BATCH: 4172588. BATCH CREATION DATE: 2024-06-20. BATCH EXPIRATION DATE: 2029-06-30. FULL UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED SYRINGES ARE MISSING PRINT. TO AID IN THE INVESTIGATION, FIVE SAMPLES WITH NO PACKAGING AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS WERE OBSERVED. THERE IS AN ACCEPTABLE IMPERFECTION IN WHICH THE LETTER 'D' FROM 'BD' IS INCOMPLETE. THE TWO PHOTOS PROVIDED SHOW ONE OF THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, LOTS 4172585 AND 4172588. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT ACCEPTABLE.

    Description of Event or Problem · 0

    MATERIAL #: 301031. BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT SYRINGES ARE MISSING PRINT ON THEM CUSTOMER HAS SYRINGES SET ASIDE TO RETURN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. LOT NUMBERS 4172585 AND 4172588.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010702 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 4172588 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown