BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIBA BIOPSY NEEDLE

    MDR report key: 3854832 · Received May 19, 2014

    Report

    Report Number
    1820334-2014-00220
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    COOK INC.
    Product Code
    DWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH OSTEOMYELITIS/DISCITIS AND LUMBAR DISC INFECTION UNDERWENT FNA LUMBAR DISC SPACE PROCEDURE ON (B)(6) 2014. AFTER THE PROCEDURE, THE DOCTOR ATTEMPTED TO REMOVE THE CHIBA NEEDLE. WHEN HE PULLED THE NEEDLE OUT IT WAS SEEN THAT APPROXIMATELY 1/2 OF THE NEEDLE REMAINED IN THE PATIENTS SOFT TISSUE. PATIENT WAS TAKEN FROM CT TO THE IR DEPARTMENT WHERE THE NEEDLE WAS REMOVED USING FLUORO GUIDANCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER. PATIENT UNDERWENT A FOREIGN BODY RETRIEVAL TO REMOVE THE REMAINING PART OF NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297853 CHIBA BIOPSY NEEDLE DWO: NEEDLE, BIOPSY, CARDIOVASCULAR DWO COOK INC. NA 4635757

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention