BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 20997347 · Received December 22, 2024

    Report

    Report Number
    1911916-2024-00941
    Event Type
    Malfunction
    Date Received
    December 22, 2024
    Date of Event
    November 11, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THE FILTER NEEDLE HAS A WHITE STAIN. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLY, WITH NO PLASTIC SHIELD, OUT OF THE PACKAGING BLISTER. THE NEEDLE HAS AN EPOXY DRIP OVER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT 3031678. 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. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    ¿ON (B)(6) 2024, OUR LOCAL PJP FORWARDED A PRODUCT DEFECT OF VABYSMO 6MG/0.05ML FROM SNEC. THEY REPORTED THAT THE TRANSFER FILTER NEEDLE OF VABYSMO 6MG/0.05ML FROM THIS BATCH WAS FOUND TO HAVE WHITE STAIN (PLEASE SEE THE ATTACHED PICTURE) PRIOR TO BEING USED WITH THE VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80837 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 3031678 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown