BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMNO NEEDLE BIOPSY 20GX20CM ADJ COAXIAL

    MDR report key: 2100959 · Received May 24, 2011

    Report

    Report Number
    9680904-2011-00015
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 7, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS NOT RECEIVED FOR EVALUATION; THEREFORE WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE ISSUE REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT REPORTED SHOWED THAT NO ISSUES WERE FOUND THAT COULD RESULT IN THE REPORTED FAILURE. IF THE SAMPLE BECOMES AVAILABLE WE WILL REOPEN THIS INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE TEMNO BIOPSY NEEDLE WAS RECEIVED WITHOUT THE COAXIAL NEEDLE FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE SHOWED THAT THE NOTCH OF THE NEEDLE WAS MISSING AND THE CANNULA WAS DAMAGED. THEREFORE; WE ARE ABLE TO CONFIRM THE ISSUE REPORTED. THE EXACT CAUSE FOR THE FAILURE COULD NOT BE DETERMINED, BUT IT IS POSSIBLE THAT THE NEEDLE COLLIDED WITH THE L2 VERTEBRA DURING THE BIOPSY PROCEDURE. DURING DHR DOCUMENTATION REVIEW, NO ISSUES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE.

    Description of Event or Problem · 1

    A 20 GAUGE TEMNO BIOPSY GUN WAS ADVANCED INTO THE SOFT TISSUE THROUGH THE 16 GAUGE COAXIAL NEEDLE AND THE TRIGGER WAS GENTLY SQUEEZED. THE TEMNO NEEDLE HOWEVER DID NOT REVEAL ANY SPECIMEN. A PORTION OF THE NEEDLE WAS MISSING. REPEAT FLUOROSCOPY DEMONSTRATED THAT THE DISTAL 1.5 CM OF THE NEEDLE HAD BROKEN OFF INTO THE LYTIC SPINOUS PROCESS OF L2. AN ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE, HOWEVER THIS ATTEMPT WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    A 20 GAUGE TEMNO BIOPSY GUN WAS ADVANCED INTO THE SOFT TISSUE THROUGH THE 16 GAUGE COAXIAL NEEDLE AND THE TRIGGER WAS GENTLY SQUEEZED. THE TEMNO NEEDLE HOWEVER DID NOT REVEAL ANY SPECIMEN. A PORTION OF THE NEEDLE WAS MISSING. REPEAT FLUOROSCOPY DEMONSTRATED THAT THE DISTAL 1.5 CM OF THE NEEDLE HAD BROKEN OFF INTO THE LYTIC SPINOUS PROCESS OF L2. AN ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE, HOWEVER THIS ATTEMPT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMNO NEEDLE BIOPSY 20GX20CM ADJ COAXIAL TEMNO NEEDLE BIOPSY 20GX20CM ADJ COAXIAL FCG CAREFUSION ACT2020 D10040631

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other| R