BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMNO NEEDLE BIOPSY 22GX15CM ADJ COAXIAL

    MDR report key: 2972752 · Received February 21, 2013

    Report

    Report Number
    9680904-2013-00005
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    CAREFUSION
    Product Code
    GDF
    PMA / PMN Number
    K902319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): TWO SAMPLES WERE RECEIVED FOR EVALUATION. ONE SAMPLE WAS UNOPENED AND FROM LOT NUMBER 0000485616. THE OTHER SAMPLE WAS OPENED. DURING THE EVALUATION, IT WAS CONFIRMED THAT THE NEEDLE THAT HAD THE BROKEN TIP HAD A GREY HANDLE AND WAS AN ACT2215 NEEDLE. DURING VISUAL INSPECTION, THIS SAME NEEDLE WAS ALSO NOTED TO CONTAIN AN OBSOLETE STICKER. THIS OBSOLETE STICKER WAS DISCONTINUED FROM USE IN PRODUCTION IN 2010 AND SINCE THEN IT HAS NOT BEEN USED IN THE MANUFACTURING PROCESS. THE TRAY, ACT2015 (LOT NUMBER: 0000485616), RECEIVED FOR EVALUATION WAS MANUFACTURED IN SEPTEMBER OF 2012, AFTER THE DISCONTINUED USE OF THE OBSOLETE STICKER. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE NEEDLE THAT WAS INTENDED TO BE USED IN THE PROCEDURE WAS AN ACT2015 (TEMNO BIOPSY NEEDLE 20GX15CM ADJ COAXIAL); HOWEVER, DURING THE PROCEDURE AN ACT2215 (TEMNO BIOPSY NEEDLE 22GX15CM ADJ COAXIAL) WAS ACTUALLY USED. THIS COULD INCREASE THE PROBABILITY OF A NEEDLE BREAKAGE AS THE ACT2215 (GREY HANDLE AND THE ACTUAL USED IN THE PROCEDURE) IS THINNER THAN THE ACT2015 (GREEN HANDLE). NO ISSUES WERE FOUND DURING REVIEW OF THE DOCUMENTATION OF INTERNAL MANUFACTURING DEVICE HISTORY RECORDS FOR THE LOT (#0000485616, ACT2015) REPORTED THAT COULD RESULT IN THE REPORTED CONDITION. A MANUFACTURING DEVICE HISTORY RECORD REVIEW FOR THE ACT2215 NEEDLE COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. AN IN-DEPTH REVIEW OF THE APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCESSES FOR THE ACT2015 AND ACT2215 PRODUCTS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES. THEREFORE, THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS REPORT AND THE IMPORTANCE OF PERFORMING 100% VERIFICATION IN THE PACKAGING AREA. THE MANUFACTURING PLANT WILL CONTINUE TO MONITOR THESE ISSUES TO IDENTIFY THE NEED FOR ANY ACTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TIP OF THE NEEDLE (APPROXIMATELY HALF INCH) BROKE OFF IN THE PATIENT'S KIDNEY. THE CUSTOMER ALLEGED THAT IT LOOKED LIKE MANUFACTURING POSSIBLY PACKAGED A 22G NEEDLE IN A 20G PACKAGING. ON (B)(6) 2013, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE SALES REPRESENTATIVE: THE PHYSICIAN WAS PERFORMING A KIDNEY BIOPSY WITH AN ACT 2015 WHEN THE TIP BROKE OFF. THE TIP IS LODGED IN THE KIDNEY. THE RADIOLOGIST TOLD THE FAMILY THAT IT WOULD NOT CAUSE ANY ISSUES AND THAT HE 'WOULD BE FINE IF THEY LEFT IT THERE.' UPON REFLECTION, THEY NOTED THAT THE NEEDLE HANDLE WAS GREY AND THEY EXPECTED IT TO BE GREEN. THE PACKAGE INDICATED CODE ACT2015, THE LOT # 0000485616. THEY NOTED THAT THEY HAD JUST OPENED A FULL BOX AND THAT THE OTHERS ARE GREEN. IT LOOKS AS THOUGH A 22 G NEEDLE WAS PACKAGED IN THE BOX OF 20 G NEEDLES LABELED AS A 20 G NEEDLE. THE OTHER NEEDLES IN THE BOX WERE CORRECT, JUST THE ONE WAS WRONG, ALL SAME PRODUCT AND LOT NUMBER. THE FACILITY HAS EXAMINED ALL OF THEIR STOCK AND THEY ARE ALL CORRECT WITH A GREEN HANDLE, WITH THE EXCEPTION OF THE INVOLVED SAMPLE. ON (B)(6) 2013, THE SALES REPRESENTATIVE INDICATED THAT THE PHYSICIAN CONSULTED WITH A UROLOGIST ABOUT LEAVING THE TIP OF THE NEEDLE IN THE PATIENT'S KIDNEY AND THIS WAS NOTED TO BE ACCEPTABLE. THE PATIENT IS ALSO NOTED TO BE DOING FINE IN TERMS OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76525 TEMNO NEEDLE BIOPSY 22GX15CM ADJ COAXIAL GUIDE, NEEDLE, SURGICAL GDF CAREFUSION ACT2215

    Patients

    Seq Age Sex Outcome Treatment
    1 TEMNO NEEDLE BIOPSY 20GX15CM ADJ COAXIAL