BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 21873078 · Received April 21, 2025

    Report

    Report Number
    1911916-2025-00290
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 28, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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 Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE ARE WHITE PARTICLES IN THE PACKAGING AND ATTACHED TO THE NEEDLES. TO AID IN THE INVESTIGATION, NINE SAMPLES AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EIGHT SAMPLES CAME IN SEALED PACKAGING BLISTERS AND ONE SAMPLE CAME WITH NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED. ALL THE SAMPLES HAVE AN EPOXY DROP OVER ON THE NEEDLE HUB. THE TWO PHOTOS PROVIDED SHOW A NEEDLE ASSEMBLY WITH AN EPOXY DRIP OVER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION OCCURS IF THERE IS A JAM AT THE CANNULATOR INDUCING THE EPOXY DRIP OVER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOTS 4212623 AND 4270137. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 305196, BATCH # 4212623, 4270137. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE WHITE PARTICLES ATTACHED TO THE NEEDLES. VERBATIM: WE HAVE FOUND 2 LOTS OF BD PRECISION GLIDE NEEDLES 18G X 1 ½ INCH REF 305196 THAT HAVE WHITE PARTICLES IN THE PACKAGING AND ATTACHED TO THE NEEDLES. THE LOTS ARE 4212623 AND 4270137. THEY WERE RECEIVED FROM XXX. CUSTOMER RESPONSE ON 16-APR-2025. DATE FIRST NOTICED: (B)(6) 2025 FOR BOTH LOTS. COULD YOU PLEASE SPECIFY WHICH LOT NUMBER HAVE "WHITE PARTICLES IN THE PACKAGING AND ATTACHED TO THE NEEDLES" LOT 4212623 AND LOT 4270137.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260670 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4270137 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown