BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-SITE

    MDR report key: 20843584 · Received December 3, 2024

    Report

    Report Number
    MW5163103
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 22, 2024
    Report Date
    November 23, 2024
    Manufacturer
    IZI MEDICAL PRODUCTS
    Product Code
    DWO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PLASTIC HUB AT TOP OF NEEDLE BROKE OFF DURING BIOPSY. NO INJURY TO PATIENT OR STAFF. ITEM- OSTEOSITE BONE MARROW BIOPSY NEEDLE REF # G36406 LOT # FP232525 EXP- 11-14-2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681941 OSTEO-SITE NEEDLE, BIOPSY, CARDIOVASCULAR DWO IZI MEDICAL PRODUCTS G36406 FP232525

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female