BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27X1-1/4 RB

    MDR report key: 18710691 · Received February 15, 2024

    Report

    Report Number
    1911916-2024-00097
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051367
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION WITH DEVICE EVALUATION. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS MDR IS FOR THE 1ST EVENT WITH UNKNOWN EVENT DATE MATERIALS#: 305136. BATCH#: 2021694. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE SNAPPING OFF AT HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER REPORTS NEEDLE SNAPPING OFF AT HUB THIS HAS HAPPENED BEFORE HOWEVER ON (B)(6) 2024 STATES GIVING INJECTION TO PATIENT AND NEEDLE SNAPPED OFF IN PATIENT BUTTOCK AND SENT TO HOSPITAL. PRODUCT#: 305136. LOT#: 2021694.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543215 NEEDLE 27X1-1/4 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON UNKNOWN 30382903051367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown