BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR BIOPSY PROBE

    MDR report key: 9954836 · Received April 13, 2020

    Report

    Report Number
    2020394-2020-02640
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Report Date
    April 13, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE FOUR MALFUNCTIONS WERE PROVIDED AND LOT HISTORY REVIEW WAS PERFORMED. FOUR DEVICES AND THREE PHOTOS HAVE BEEN RETURNED FOR THE FOUR MALFUNCTIONS; FOUR MALFUNCTIONS IDENTIFIED 2944 - DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. BASED UPON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ECP0110G BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE THREE MALFUNCTIONS, THREE DID NOT INVOLVE PATIENTS, AND ONE INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE WEIGHT OF TWO PATIENTS RANGED FROM 151-158 LBS. THE AGE, WEIGHT, AND GENDER OF THE OTHER PATIENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418533 ENCOR BIOPSY PROBE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. ECP0110G VTDU0512, VTDU0487 00801741086243

    Patients

    Seq Age Sex Outcome Treatment
    1