BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR DRIVER

    MDR report key: 12141126 · Received July 9, 2021

    Report

    Report Number
    2020394-2021-01295
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 10, 2021
    Report Date
    October 1, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086076
    PMA / PMN Number
    K040842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE EVENT WAS DETERMINED TO BE EXPECTED AND THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING AND/OR SERVICE-RELATED ISSUES. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS OR VIDEO WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRIVER ACTIVATED AND BEGAN SAMPLING WHILE IN THE HOLDER(SAMPLE BUTTON NOT BEING PRESSED) WAITING FOR THE PROCEDURE FOR ABOUT 20 MINUTES. NEEDLE WAS CHANGED, DRIVER PORT WAS CHANGED AND IT STILL HAD SAME ISSUE. DEVICE WAS THEN HOOKED UP TO AN ALTERNATE SYSTEM AND SEEMED TO CORRECT ITSELF. THERE WAS NO PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 12/2099).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER ACTIVATED AND BEGAN SAMPLING WHILE IN THE HOLDER(SAMPLE BUTTON NOT BEING PRESSED) WAITING FOR THE PROCEDURE FOR ABOUT 20 MINUTES. NEEDLE WAS CHANGED, DRIVER PORT WAS CHANGED AND IT STILL HAD SAME ISSUE. DEVICE WAS THEN HOOKED UP TO AN ALTERNATE SYSTEM AND SEEMED TO CORRECT ITSELF. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039370 ENCOR DRIVER REUSABLE BIOPSY KNW BARD PERIPHERAL VASCULAR, INC. DRENCOR 00801741086076

    Patients

    Seq Age Sex Outcome Treatment
    1 Other