BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TRANSURETHRAL INJECTION SYSTEM

    MDR report key: 1014072 · Received March 14, 2008

    Report

    Report Number
    1018233-2008-00015
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    January 9, 2008
    Report Date
    March 14, 2008
    Manufacturer
    C. R. BARD, INC.
    Product Code
    LNM
    PMA / PMN Number
    P900030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED COMPONENT LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. SAMPLE RECEIVED WAS EVALUATED. THE METAL NEEDLE TIP WAS REVIEWED UNDER 10X MAGNIFICATION AND WAS NOTED TO BE OFF CENTER COMPLETELY TOUCHING ONE SIDE OF THE CANNULA. IT APPEARS THAT THE POLYCARBONATE CANNULA WAS KINKED AT THE REAR OF THE STAINLESS STEEL NEEDLE CAUSING THE STAINLESS STEEL NEEDLE TO BREAK THROUGH THE POLYCARBONATE CANNULA WITH AN UNEVEN SURFACE. THIS RESULTED IN BREAKING OF THE DEVICE AWAY FROM THE POLYCARBONATE CANNULA. THE NEEDLE ASSEMBLY WAS REVIEWED AT THE DISTAL END WHERE THE NEEDLE TIP WOULD HAVE ATTACHED, UNDER 10X MAGNIFICATION, IT WAS NOTED TO HAVE AN UNEVEN SURFACE. PER CALIBRATED EQUIPMENT, THE POLYCARBONATE SHAFT WITH THE STRAIN RELIEF AND HUB ATTACHED WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION REQUIREMENTS. THE TOTAL LENGTH OF THE POLYCARBONATE CANNULA PER THE SPECIFICATION SHOULD BE 13.14 +0.05 / -0.10 INCHES. THE RETURNED SAMPLE MEASURED (2 PIECES) APPROX 13.1510 INCHES WHICH IS WITHIN SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BULKING IMPLANT PROCEDURE IN EARLY 2008, THE NEEDLE SNAPPED WITHOUT UNDUE TENSION AND ENDED UP INSIDE THE PT'S BLADDER. THE NEEDLE PIECE WAS RETRIEVED USING GRASPERS WITHOUT ANY DAMAGE TO THE PT. ANOTHER NEEDLE WAS USED SUCCESSFULLY. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD TRANSURETHRAL INJECTION SYSTEM LNM C. R. BARD, INC. NA CVRG0001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK