BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 7617588 · Received June 19, 2018

    Report

    Report Number
    2020394-2018-00920
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 18, 2018
    Report Date
    October 3, 2018
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741084423
    PMA / PMN Number
    K133948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: ONE MAXCORE BIOPSY NEEDLE WAS RETURNED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE TOP SLIDE COULD NOT BE LOCKED INTO THE PRIMED POSITION. UPON DISASSEMBLY, THE LEFT BUMPER WAS NOTED TO BE BENT AND A CANNULA TANG SHORT SHOT WAS IDENTIFIED. THEREFORE THE INVESTIGATION IS CONFIRMED FOR CANNULA PRIMING ISSUES AND DEFECTIVE COMPONENTS. HOWEVER, THE COMPLAINT WILL REMAIN INCONCLUSIVE FOR THE ALLEGED SELF-ACTIVATION, AS FUNCTIONAL TESTING IS NOT POSSIBLE DUE TO THE IDENTIFIED FAILURES. THE ROOT CAUSE OF THE CANNULA PRIMING ISSUE WAS DETERMINED TO BE SUPPLIER RELATED, THE SHORT-SHOT CANNULA TANGS COULD ONLY OCCUR DURING MOLDING. MANUFACTURER ISSUED QA-17-0723 TO ADDRESS THE IDENTIFIED SHORT-SHOT. LABELING REVIEW: THE REVIEW OF THE IFU (INSTRUCTIONS FOR USE), INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BIOPSY PROCEDURE IN NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY SELF ACTIVATED. NO COAXIAL WAS USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BIOPSY PROCEDURE IN NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY SELF ACTIVATED. NO COAXIAL WAS USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458023 MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REBT0380 00801741084423

    Patients

    Seq Age Sex Outcome Treatment
    1