BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENTS

    MDR report key: 6068188 · Received October 31, 2016

    Report

    Report Number
    2020394-2016-01020
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K133948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA. VISUAL/MICROSCOPIC INSPECTION: THE DEVICE WAS NOT RETURNED; THEREFORE, A VISUAL/MICROSCOPIC INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE DEVICE WAS NOT RETURNED; THEREFORE, A FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLES WERE NOT RETURNED FOR EVALUATION. PER THE REPORTED EVENT DETAILS, THE DEVICE WAS DRY FIRED PRIOR TO USE. THE INSTRUCTIONS FOR USE (IFU) STATES, PRECAUTIONS: "NEVER TEST THE PRODUCT BY FIRING INTO THE AIR. DAMAGE MAY OCCUR TO THE NEEDLE/CANNULA TIP." THEREFORE, IT IS POSSIBLE THAT PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: THE CURRENT MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENTS IFU PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. 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 AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH SCATTERED DENSITY TISSUE, THE FIRST SLIDE ALLEGEDLY WOULD RELEASE AFTER THE FIRST SAMPLE PASS. IT WAS FURTHER REPORTED THAT THE FIRST SLIDE WOULD ALLEGEDLY LOCK INTO PLACE BUT WOULD RELEASE AFTER THE HEALTH CARE PROVIDER ATTEMPTED TO PRIME THE SECOND SLIDE. REPORTEDLY, A COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719041 MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENTS BIOPSY INSTUMENT KNW BARD PERIPHERAL VASCULAR, INC. REAU1528

    Patients

    Seq Age Sex Outcome Treatment
    1