BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1 RB

    MDR report key: 21103371 · Received January 8, 2025

    Report

    Report Number
    1911916-2024-00984
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    November 25, 2024
    Report Date
    January 25, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051251
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THE NEEDLE IS ACTING BLOCKED AND WON¿T INJECT. TO AID IN THE INVESTIGATION, EIGHT HUNDRED FORTY-FOUR SAMPLES IN SEALED PACKAGING BLISTERS WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EIGHTY SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION, A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305125, LOT 4060114. 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. 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. NO ADVERSE EVENT.

    Description of Event or Problem · 0

    MATERIAL: 305125 BATCH#: 4060114 VERBATIM: THE NEEDLE IS ACTING BLOCKED AND WON¿T INJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883144 NEEDLE 25X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4060114 30382903051251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown