BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 6426625 · Received March 22, 2017

    Report

    Report Number
    2020394-2017-00239
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    February 24, 2017
    Report Date
    June 6, 2017
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741084645
    PMA / PMN Number
    K133948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER OF THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. VISUAL INSPECTION: THE SAMPLE WAS RETURNED WITH THE ARROW VISIBLE IN THE READY WINDOW, THUS INDICATING THE DEVICE WAS IN THE "READY TO FIRE STATE" WITH THE STYLET AND CANNULA RETRACTED (PRIMED). THERE WERE NO VISUAL ANOMALIES NOTED ON THE DEVICE. FUNCTIONAL/PERFORMANCE EVALUATION: THE FIRING TRIGGER WAS PRESSED AND BOTH THE CANNULA AND STYLET ADVANCED. THE SAMPLE WAS DISASSEMBLED TO MEASURE THE LENGTH OF THE CANNULA AND THE STYLET. THE LENGTH OF THE CANNULA WAS MEASURED AND FOUND TO BE 8.170". THIS MEASUREMENT WAS NOT WITHIN SPECIFICATION FOR A 121816 NEEDLE; HOWEVER, IT WAS IN SPECIFICATION FOR A 121820 NEEDLE. THE LENGTH OF THE STYLET WAS 10.257". THIS MEASUREMENT WAS NOT WITHIN SPECIFICATION FOR A 121816 NEEDLE; HOWEVER, IT WAS IN SPECIFICATION FOR A 121820 NEEDLE. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. IMAGE/PHOTO REVIEW: IMAGES WERE NOT PROVIDED FOR REVIEW CONCLUSION: A DIMENSIONAL EVALUATION WAS PERFORMED AND IT WAS FOUND THAT THE NEEDLE WAS OUT OF SPECIFICATION FOR A 121816 MONOPTY NEEDLE, AS LABELED, BUT WAS WITHIN SPECIFICATION FOR A 121820 MONOPTY NEEDLE. ADDITIONALLY, A SALES REVIEW AND A MANUFACTURING REVIEW WERE PERFORMED. BASED ON THE ADDITIONAL INVESTIGATION ACTIVITIES AND THE REPORTED EVENT DETAILS, THE INVESTIGATION CANNOT BE CONFIRMED FOR A MISLABEL. THEREFORE, THE INVESTIGATION WAS INCONCLUSIVE. PER THE SALES REVIEW, IT WAS NOTED THAT THE FACILITY HAD NOT PURCHASED A 121820 NEEDLE SINCE AUGUST 2015. THE REPORTED EVENT OCCURRED IN (B)(6) 2016. ADDITIONALLY, PER THE REPORTED EVENT DETAILS, THE COMPLAINANT NOTED THAT THE ALLEGED DEVICE WAS THE ONLY ONE BROUGHT INTO THE PROCEDURE. HOWEVER, IT IS UNKNOWN IF A MIX-UP MAY HAVE OCCURRED AT THE FACILITY. ADDITIONALLY, PER THE MONOPTY INSTRUMENT ASSEMBLY PROCEDURE, THE NEEDLE LENGTH IS 100% VERIFIED DURING A DRY FIRE TEST. IF THE NEEDLE HAS A LONGER LENGTH, THE NEEDLE WILL BEND UPON CONTACT WITH THE TEST FIXTURE. THEREFORE, IT IS HIGHLY UNLIKELY THAT A LONGER NEEDLE WOULD HAVE BEEN MIXED UP WITH A BATCH OF SHORTER NEEDLES AT MANUFACTURING. BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. AN INTERNAL INVESTIGATION HAS BEEN OPENED UP TO FURTHER INVESTIGATE THIS ISSUE. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: GENERAL INFORMATION AND DEVICE DESCRIPTION: THE BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT IS A SINGLE USE CORE BIOPSY DEVICE. IT IS AVAILABLE IN SEVERAL NEEDLE GAUGE SIZES AND LENGTHS. PRECAUTIONS: BEFORE USING, INSPECT THE NEEDLE FOR DAMAGED POINT, BENT SHAFT OR OTHER IMPERFECTIONS THAT WOULD PREVENT PROPER FUNCTION. IF THE NEEDLE COMPONENTS ARE DAMAGED OR BENT, DO NOT USE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KIDNEY BIOPSY, THE PHYSICIAN NOTICED THAT THE NEEDLE ALLEGEDLY APPEARED TO BE LONGER THAN WHAT WAS INDICATED ON THE PACKAGING LABEL AFTER TAKING ONE TISSUE SAMPLE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KIDNEY BIOPSY, THE PHYSICIAN NOTICED THAT THE NEEDLE ALLEGEDLY APPEARED TO BE LONGER THAN WHAT WAS INDICATED ON THE PACKAGING LABEL AFTER TAKING ONE TISSUE SAMPLE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207761 MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REAU0328 00801741084645

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR