BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR DRIVER

    MDR report key: 15803910 · Received November 16, 2022

    Report

    Report Number
    2020394-2022-00899
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    September 26, 2022
    Report Date
    November 18, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086076
    PMA / PMN Number
    K040842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 12/2099).

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THIS EVENT IS DETERMINED TO BE EXPECTED AND A POTENTIAL OUT OF BOX FAILURE ISSUE WAS IDENTIFIED, THEREFORE A DEVICE HISTORY RECORD REVIEW AND MANUFACTURING REVIEW IS REQUESTED. INVESTIGATION INDICATES THAT THE REPORTED ISSUE WAS UNCONFIRMED AND WAS NOT A MANUFACTURING OR SUPPLIER RELATED ISSUE.   INVESTIGATION SUMMARY: THE ENCOR DRIVER WAS RECEIVED FOR EVALUATION. THE ENCOR DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE IN GOOD OVERALL CONDITION AND FUNCTIONS NORMALLY. ALSO, FOUND THAT THE SENSOR COVER WAS SCRATCHED. THE DEVICE WAS FUNCTIONALLY TESTED AND PASSED THE TESTS DURING EVALUATION. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, INVESTIGATION IS DETERMINED TO BE UNCONFIRMED FOR REPORTED DEVICE SAMPLING WITHOUT PRESSING BUTTONS AS SOON AS ATTACHED TO FIRE FORWARD. THE ROOT CAUSE FOR THE DEVICE SAMPLING WITHOUT PRESSING BUTTONS AS SOON AS ATTACHED TO FIRE FORWARD CANNOT BE DETERMINED AS THE PROBLEM COULD NOT BE REPRODUCED. 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. H10: D4 (EXPIRY DATE: 12/2099). 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

    IT WAS REPORTED THAT PRIOR TO BIOPSY PROCEDURE, THE DEVICE IS ALLEGEDLY SAMPLING WITHOUT PRESSING BUTTONS AS SOON AS ATTACHED TO FIRE FORWARD. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO BIOPSY PROCEDURE, THE DEVICE IS ALLEGEDLY SAMPLING WITHOUT PRESSING BUTTONS AS SOON AS ATTACHED TO FIRE FORWARD. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350731 ENCOR DRIVER BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. DRENCOR 00801741086076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown