BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA

    MDR report key: 21207047 · Received January 22, 2025

    Report

    Report Number
    1213809-2024-01059
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    December 17, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT CONFIRMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. 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

    MATERIAL # 305270. LOT # UNKNOWN. IT WAS REPORTED THAT THE BD INTEGRA NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: INTEGRA NEEDLE BROKE OFF WHEN BEING INJECTED INTO A PTS UPPER/OUTER QUADRANT OF RT GLUTEUS. HAD TO MAKE AN INCISION IN THE PATIENT TO EXPLORE THE AREA TO FIND THE NEEDLE, BUT IT WAS NOT FOUND IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943594 BD INTEGRA SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other