BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACKERMANN BONE BIOPSY NEEDLE SET

    MDR report key: 4071239 · Received September 2, 2014

    Report

    Report Number
    1820334-2014-00414
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    April 12, 2014
    Report Date
    August 8, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT PROVIDED BY THE REPORTER. LOT NUMBER WAS NOT PROVIDED BY THE REPORTER. EXP DATE UNK AS LOT IS UNK. NAME OF FACILITY WAS NOT PROVIDED BY THE REPORTER. (B)(4).

    Description of Event or Problem · 1

    THE FEMALE PT CALLED THE MFR, REPORTING THAT AN INCIDENT OCCURRED SOMETIME IN (B)(6) 2014 AT A HOSPITAL; INVOLVING ABC-100 BONE BIOPSY NEEDLE. ADDITIONAL INFO WAS PROVIDED STATING THAT DURING THE PROCEDURE, THE TURN HANDLE BROKE OFF OF THE NEEDLE AND THE NEEDLE BECAME STUCK IN THE PT'S FOOT. THE PT SAID THAT THIS PROCEDURE SHOULD HAVE LASTED 45 MINUTES BUT ENDED UP LASTING OVER 2 HRS DUE TO THE TIME REQUIRED TO REMOVE THE BROKEN NEEDLE FROM HER FOOT. THE PT SAID SHE WAS CONSCIOUS FOR THE ENTIRE PROCEDURE. OTHER DOCTORS WERE BROUGHT IN TO HELP. ACCORDING TO THE PT, THE BROKEN NEEDLE WAS ULTIMATELY REMOVED FROM HER FOOT DURING THIS PROCEDURE AFTER THE DOCTORS HAD ATTEMPTED DIFFERENT SOLUTIONS INCLUDING, PULLING, GRABBING, AND HITTING THE NEEDLE WITH A HAMMER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532328 ACKERMANN BONE BIOPSY NEEDLE SET NEEDLE, BIOPSY, CARDIOVASCULAR DWO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Required Intervention