BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD BRACHYSTAR SEED IMPLANT NEEDLE

    MDR report key: 1657652 · Received April 8, 2010

    Report

    Report Number
    1018233-2010-00030
    Event Type
    Malfunction
    Date Received
    April 8, 2010
    Date of Event
    March 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    IWJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. AN ANALYSIS OF THE LABELING FOUND THE FOLLOWING: CAUTION - NEEDLES ARE NOT INTENDED TO PENETRATE BONE. IF RESISTANCE IS ENCOUNTERED, VERIFY NEEDLE POSITION. DO NOT PUSH INTO BONE; THIS MAY CAUSE NEEDLE TO BEND OR BREAK. REPLACE NEEDLE IF CANNULA, OR POINT, IS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE NEEDLE WAS REMOVED FROM THE PT, THE NEEDLE WAS CRACKED ABOUT 1/3 OF THE WAY UP. THE NEEDLE DID NOT BREAK OFF IN THE PT, IT WAS INTACT UPON REMOVAL WITH THE EXCEPTION OF THE CRACK. THE DR WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD BRACHYSTAR SEED IMPLANT NEEDLE IWJ C.R. BARD, INC. NA RETH0167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA