BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21230555 · Received January 24, 2025

    Report

    Report Number
    1911916-2025-00045
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    November 21, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE IS CORING WHEN USING THE BLUNT NEEDLES. TO AID IN THE INVESTIGATION, TWO SAMPLES IN OPENED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION. THERE WAS NO DAMAGE, DEFECTIVE GRIND OR HOOKS OBSERVED. THE BEVELS AND ETCH WERE GOOD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 4212669. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE 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

    MATERIAL#: 305180 . BATCH#: 4212669 . VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED IT WAS REPORTED BY THE CUSTOMER THAT OUR ANAESTHESIA TEAM AND OUR AA ARE FINDING MORE AND MORE WHEN USING THE BLUNT NEEDLES ARE FINDING CORING. THIS IS HAPPENING WITH MANY DRUG VIALS AND IN MANY OF THE SYRINGES WHEN DRAWING UP. SAME ISSUE AT THE SAME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555439 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4212669 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown