BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR MRI DRIVER

    MDR report key: 15376457 · Received September 8, 2022

    Report

    Report Number
    2020394-2022-00727
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    May 15, 2022
    Report Date
    September 27, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086083
    PMA / PMN Number
    K040842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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: 09/2045).

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD 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 UNINTENDED MOVEMENT 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: 09/2045), G3, H6 (METHOD). 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 DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO STOP SAMPLING AND RESULTED IN TAKING AROUND 5 EXTRA SAMPLES THAT WAS NOT REQUIRED. THE VACUUM BUTTON WAS PRESSED TO FORCE STOP THE SAMPLING. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO STOP SAMPLING AND RESULTED IN TAKING AROUND 5 EXTRA SAMPLES THAT WAS NOT REQUIRED. THE VACUUM BUTTON WAS PRESSED TO FORCE STOP THE SAMPLING. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254779 ENCOR MRI DRIVER REUSABLE BIOPSY KNW BARD PERIPHERAL VASCULAR, INC. DRENCORMR 00801741086083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown