BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR FIRE FORWARD

    MDR report key: 15859724 · Received November 24, 2022

    Report

    Report Number
    2020394-2022-00923
    Event Type
    Malfunction
    Date Received
    November 24, 2022
    Date of Event
    October 28, 2022
    Report Date
    December 6, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086458
    PMA / PMN Number
    K040842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. EXPIRATION DATE: 11/2045.

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE DEVICE WAS NOT RETURNED. 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. A DEFINITIVE ROOT CAUSE FOR THE UNSTABLE DEVICE COULD NOT BE DETERMINED BASED UPON THE PROVIDED 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. H10: D4 (EXPIRATION DATE: 11/2045), G3 H11: H6 (RESULT, CONCLUSION) 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY UNSTABLE WHEN ATTACHED TO THE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY UNSTABLE WHEN ATTACHED TO THE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759171 ENCOR FIRE FORWARD BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. ENCFF02 00801741086458

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown