BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEMNO NEEDLE BIOPSY 20 G X 15 CM ADJ COAXIAL

    MDR report key: 1215660 · Received October 21, 2008

    Report

    Report Number
    1423507-2008-00084
    Event Type
    Other
    Date Received
    October 21, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 21, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ISSUES WERE IDENTIFIED WHILE PERFORMING THE MANUFACTURING DOCUMENTATION REVIEW. THE SAMPLE THAT WAS RECEIVED CONFIRMED THE REPORTED FAILURE MODE. THE CANNULA OF THE COAXIAL THAT GOES WITH THE ACT2015 NEEDLE WAS BROKE. FROM VISUAL INSPECTION IT WAS NOTICED THAT THE CANNULA WAS BENT AND NEAR THE BREAKAGE SITE; PRESENTED A KINKED CONDITION. THE FAILURE MODE REPORTED IS NOT THOUGHT TO BE RELATED WITH THE ASSEMBLY/INSPECTION PROCESS DEFINED BY PROCEDURES. PROCEDURES CALLED FOR A VISUAL AND FUNCTIONAL VERIFICATION OF NEEDLES PRIOR TO RELEASE OF THE PRODUCT TO THE NEXT STAGE. BASED ON THE INCIDENT DESCRIPTION AND THE BIOPSY SITE INDICATED (LIVER), IT IS POSSIBLE THAT BENDING WAS A RESULT OF MOVEMENT DURING THE BIOPSY PROCEDURE. WHILE PERFORMING LIVER BIOPSY IT IS POSSIBLE THAT THE NEEDLE COULD BE PLACED IN CLOSE PROXIMITY TO THE RIBS AND BECOME BENT IF IT COMES INTO CONTACT WITH A RIB DUE TO PT MOVEMENT. AS A PREVENTIVE MEASURE MANUFACTURING PERSONNEL WILL BE MADE AWARE OF THIS INCIDENT IN ORDER TO MAKE THEM AWARE OF THE IMPORTANCE OF VERIFYING CONDITION OF THE COMPONENTS PRIOR TO ASSEMBLY.

    Description of Event or Problem · 1

    THE COAXIAL NEEDLE HAS SNAPPED OFF DURING THE PROCEDURE. PT WAS SENT TO THEATRE (OPERATING ROOM) TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMNO NEEDLE BIOPSY 20 G X 15 CM ADJ COAXIAL SOFT TISSUE BIOPSY NEEDLE KNW CARDINAL HEALTH ACT2015 D07040638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention