BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUCUT BONE BIOPSY NEEDLES

    MDR report key: 1591215 · Received November 9, 2009

    Report

    Report Number
    2411512-2009-00001
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Date of Event
    June 8, 2008
    Report Date
    November 6, 2009
    Manufacturer
    BRACCO DIAGNOSTICS, INC
    Product Code
    KNW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08-OCT-2009, BRACCO REC'D THIS REPORT BY REGULAR MAIL FROM THE FOOD AND DRUG ADMIN WHERE IT HAD BEEN ASSIGNED FDA NUMBER (B)(4). THE FDA REC'D THIS REPORT FROM A RISK MGR. NO CONTACT INFO FOR THE RISK MGR OR THE USER FACILITY WAS PROVIDED BY THE FDA. FOLLOW UP INFO WOULD BE DESIRABLE, HOWEVER NO CONTACT INFO WAS PROVIDED FOR THE REPORTING RISK MGR OR THE USER FACILITY. BRACCO DOES NOT CURRENTLY ANTICIPATE OBTAINING FOLLOW UP INFO FROM THE RISK MGR OR USER FACILITY FOR THIS REPORT. BRACCO IS CONDUCTING AN INVESTIGATION OF ITS MFG RECORDS AND RETAINS. THE RESULTS OF BRACCO'S INVESTIGATION ARE NOT YET AVAILABLE. COMPANY COMMENTS: THE BREAKAGE OF THE TIP OF THE BIOPSY NEEDLE THAT IS REPORTED IS MOST PROBABLY PROCEDURAL RELATED.

    Description of Event or Problem · 1

    NARRATIVE: ON 08-OCT-2009, BRACCO REC'D THIS REPORT OF A DEVICE MALFUNCTION FROM THE FOOD AND DRUG ADMIN BY MAIL. THE FDA IDENTIFICATION NUMBER FOR THE REPORT IS (B)(4). THE FDA REPORTED: ON (B)(6) 2009, A RISK MGR WHO IS A HEALTH PROF REPORTED TO THE FDA A DEVICE MALFUNCTION. ON (B)(6) 2009, THE TIP OF A BIOPSY NEEDLE BROKE OFF IN THE LUMBAR VERTEBRAE DURING A BONE BIOPSY PROCEDURE. THE BONE BIOPSY NEEDLE BRAND IS PERCUCUT E-Z-EM, DEVICE TYPE IS 600504, CATALOG NUMBER IS N710 AND LOT NUMBER IS 20038179. THE DEVICE IS NOT REPROCESSED AND REUSED. THE DEVICE IS NOT AVAILABLE FOR EVAL. ON 26-OCT-2009, THE RESULTS OF BRACCO'S INVESTIGATION BECAME AVAILABLE. TWO UNUSED NEEDLES FROM LOT 20038179 WERE EXAMINED. A VISUAL INSPECTION WAS PERFORMED INCLUDING STYLET/HUB COLOR, MEASUREMENTS OF THE CANNULA AND STYLET OD, AND THE USABLE LENGTH. THE INSPECTION WAS DONE IN ACCORDANCE WITH BRACCO'S RELEVANT SOP. THE INVESTIGATION CONCLUDED BOTH SAMPLES PASSED QC INSPECTION AND MET THE DEFINED SPECIFICATION REQUIREMENTS. NO QUALITY DEFECTS WERE DETECTED. BRACCO DID NOT ATTRIBUTE THE REPORTED SITUATION TO A PRODUCT DEFECT, AND THE ROOT CAUSE FOR THE SITUATION COULD NOT BE CONCLUSIVELY DETERMINED. IT SHOULD BE NOTED THAT USER TECHNIQUE CANNOT BE RULED OUT. THE "CAUTIONS" SECTION OF THE PRODUCT IFU STATES THE FOLLOWING: "DO NOT ATTEMPT TO REMOVE THE NEEDLE BY OSCILLATING THE CANNULA. THIS MAY CAUSE THE NEEDLE TIP TO FRACTURE. INSTEAD REMOVE IT BY SIMULTANEOUSLY APPLYING COUNTERCLOCKWISE ROTATION AND TRACTION." IN ADDITION, A REVIEW OF THE HISTORICAL COMPLAINT HISTORY FOR THE PERCUCUT BIOPSY NEEDLE WAS CONDUCTED. THIS REVEALED ONLY ONE SIMILAR COMPLAINT (BRACCO/E-Z-EM FILE NUMBER (B)(4)). BRACCO'S E-Z-EM'S MEDICAL DIRECTOR DEEMED THAT THIS IS NOT AN UNCOMMON OR UNEXPECTED SITUATION. THE TIP IS USUALLY LEFT INSIDE THE BONE WITH NO ADVERSE CONSEQUENCE TO THE PT RELATED TO THIS PARTICULAR EVENT. BRACCO'S MANUFACTURER OF THE PRODUCT (B)(4) WAS CONTACTED AND REQUESTED TO REVIEW THEIR RECORDS AS THEY PERTAIN TO THIS EVENT. (B)(4) RESPONDED ON 16-OCT-2009 CONCLUDING THERE WERE NO NON-CONFORMANCE ISSUES DURING THE MFG FOR LOT 20038179. NOTE: DURING INSPECTION OF THE NEEDLES, IT WAS NOTICED THAT THE BLUNT OBTURATOR IS NOT PROPERLY SEATED IN THE HUB AND THE OBTURATOR TILTS ABOUT 10 DEGREES. IT IS NOT BELIEVED THAT THIS COSMETIC ISSUE WAS IN ANY WAY ASSOCIATED TO THE COMPLAINT REPORT, AS THE OBTURATOR DOES NOT ENTER THE BODY AND THIS IS ONLY USED TO PUSH THE BIOPSY SPECIMEN INTO THE PREFERRED FIXING SOLUTION. THIS CASE IS MEDICALLY CLOSED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUCUT BONE BIOPSY NEEDLES I KNW BRACCO DIAGNOSTICS, INC 600504 20038179

    Patients

    Seq Age Sex Outcome Treatment
    1