BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 20932785 · Received December 14, 2024

    Report

    Report Number
    1911916-2024-00905
    Event Type
    Malfunction
    Date Received
    December 14, 2024
    Date of Event
    November 19, 2024
    Report Date
    January 12, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THE MEDICATION SHOOTS OUT OF A HOLE INSTEAD OF THE NEEDLE. TO AID IN THE INVESTIGATION, ONE HUNDRED FORTY-SEVEN SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. FIFTY SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH OF THE FIFTY SAMPLES WERE THEN ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION; THE SOLUTION EXPELLED WITH A NORMAL FLOW. NO LEAKAGE OR ANY OTHER ISSUES WERE OBSERVED. THE PHOTO PROVIDED SHOWS A NEEDLE ASSEMBLY HUB WITH THE GATE MARK WHERE THE RESIN IS FILLED TO THE MOLDING TOOL. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305127, LOT 3083311. 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. WITHOUT THE ACTUAL DEFECTIVE SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL # 305127 BATCH # 3083311. CUSTOMER SAID WHEN PUSHING MEDICATION, IT SHOOTS OUT THE HOLE INSTEAD OF THE NEEDLE. NO PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282095 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3083311 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown