BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MAXCORE DISPOSABLE BIOPSY INSTRUMENT

    MDR report key: 8485572 · Received April 4, 2019

    Report

    Report Number
    2020394-2019-00230
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741084454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER FOR THE TWO MALFUNCTIONS WERE PROVIDED AND LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES HAVE BEEN RETURNED FOR EVALUATION; THE EVALUATION IDENTIFIED SELF-ACTIVATION AND FAILURE TO PRIME FOR BOTH MALFUNCTIONS. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL MC1616 BIOPSY INSTRUMENT EXPERIENCED FAILURE TO PRIME AND SELF-ACTIVATION. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE 2 EVENTS, BOTH INVOLVED PATIENTS WITH NO REPORTED INJURY. ONE EVENT INVOLVED A MALE PATIENT 54-YEAR-OLD AND WEIGHING 67 KGS, THE OTHER INVOLVED A 39-YEAR-OLD MALE WEIGHING 62 KGS.

    Additional Manufacturer Narrative · 1

    THE 2 DEVICES FOR THESE EVENTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL MC1616 BIOPSY INSTRUMENT EXPERIENCED FAILURE TO PRIME AND SELF-ACTIVATION. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE 2 EVENTS, BOTH INVOLVED PATIENTS WITH NO REPORTED INJURY. I EVENT INVOLVED A MALE PATIENT (B)(6) YEARS OLD AND WEIGHING (B)(6) KGS, THE OTHER PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277435 BARD MAXCORE DISPOSABLE BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. MC1616 REBP0867, REBX1327 00801741084454

    Patients

    Seq Age Sex Outcome Treatment
    1