BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21207725 · Received January 22, 2025

    Report

    Report Number
    1911916-2025-00034
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 23, 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 BLUNT FILL NEEDLES ARE TAKING RUBBER FROM THE MEDICATION VIALS. TO AID IN THE INVESTIGATION, TWO SAMPLES IN OPENED PACKAGING BLISTERS, THREE SYRINGES, TWO MEDICATION VIALS AND THREE PHOTOS 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 ON THE NEEDLES. THE BEVELS AND ETCH WERE GOOD. THE THREE SYRINGES RECEIVED HAVE A PARTICLE THAT APPEARS TO BE OF A SIMILAR MATERIAL OF THE STOPPER VIAL. THE THREE PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. 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 IS CONFIRMED, BUT A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. THE NEEDLES RETURNED MET OUR SPECIFICATION REQUIREMENTS.

    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

    ADDITIONAL INFORMATION RECEIVED: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE THAT WE ARE CURRENTLY AWARE OF.

    Description of Event or Problem · 0

    MATERIAL#: 305180. BATCH NUMBER#: 4212669. VERBATIM#: WE ARE EXPERIENCING AN ISSUE WITH OUR BLUNT FILL NEEDLES. WHAT¿S HAPPENING IS OUR ICU NURSES FINDING THAT THE BLUNT FILL NEEDLES ARE PUNCTURING VIALS, BUT TAKING WITH THEM RUBBER FROM THE VIALS, WHICH THEN NURSES ARE SEEING WHEN THEY ARE DRAWING UP MEDIATIONS. WE ARE NOT SURE WHY IN THE LAST FEW WEEKS WE HAVE BEEN SEEING THIS MORE OFTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621681 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