BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MAGNUM REUSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 10789966 · Received November 5, 2020

    Report

    Report Number
    2020394-2020-20342
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    September 29, 2020
    Report Date
    May 27, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741083945
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, DR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: AS THE DEVICE WAS NOT RETURNED, AND NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, DEVICE HISTORY RECORD AND MANUFACTURING REVIEWS ARE NOT REQUIRED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED; THEREFORE, THE SERVICE DEPOT EVALUATION COULD NOT BE PERFORMED. AS THE EVALUATION COULD NOT BE PERFORMED, THE INVESTIGATION IS INCONCLUSIVE, AND THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. LABELING REVIEW: THE REVIEW OF THE INSTRUCTIONS FOR USE, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY SELF ACTIVATED. THERE WAS NO PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRY DATE: 12/2099).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY SELF ACTIVATED. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261504 BARD MAGNUM REUSABLE CORE BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. MG1522 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 Other