BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 21290595 · Received February 3, 2025

    Report

    Report Number
    1911916-2025-00074
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 25, 2025
    Report Date
    February 28, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. IT WAS REPORTED THERE WAS AN EXCESSIVE AMOUNT OF VIAL CORING. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A 20ML SYRINGE WITH A NEEDLE ASSEMBLY AND A BAG WITH SOLUTION. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 4212628. 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. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE PHYSICAL NEEDLE SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL #305196 AND LOT 4212628. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WANTED TO REACH OUT TO REPORT THAT WE HAVE BEEN HAVING AN EXCESSIVE AMOUNT OF VIAL CORING WHEN WE USE THE PRODUCT BELOW. HAS SOMETHING CHANGED WITH THIS PARTICULAR NEEDLE THAT MAY BE IMPACTING THE QUALITY? WE HAVE NOT HAD ANY OTHER CHANGES IN THE MEDICATION PRODUCTS THAT ARE BEING CORED AND ARE WONDERING IF IT COULD BE A NEEDLE MALFUNCTION AT THIS POINT. SOME OF THE RECENT PRODUCTS IDENTIFIED AS BEING CORED WITHIN THE LAST WEEK ARE NOTED BELOW. ALSO NOTE THAT DIFFERENT PEOPLE WERE INVOLVED WITH COMPOUNDING THE DIFFERENT PRODUCTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166231 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4212628 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown