BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE

    MDR report key: 14191695 · Received April 25, 2022

    Report

    Report Number
    2020394-2022-00317
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 30, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741084447
    PMA / PMN Number
    K133948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT 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: 01/2023).

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: ONE SEALED MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENT WAS RETURNED FOR EVALUATION. ON VISUAL EVALUATION, IT WAS NOTED THAT THERE WAS RUST ON THE DEVICE. AND RED SPECKS WERE NOTED TO THE DISTAL TIP OF THE NEEDLE AND AREAS OF THE OUTER HOUSING . AS ADDITIONAL EVALUATION, SEM ANALYSIS WAS PERFORMED. THE ANALYSIS INDICATED THAT THE RED MATERIAL IS MADE UP OF OXYGEN, CHLORINE, IRON AND CHROMIUM WITH MINOR SILICON AND NICKER. THE SEM ANALYSIS CONCLUDED THAT THERE WAS A PRESENCE OF CHLORINE DETECTED WHICH WILL READILY CORRODE STAINLESS STEEL (IN THE PRESENCE OF MOISTURE). AND IT WAS FURTHER NOTED THAT OTHER THAN CHLORINE, NO OTHER CORRODING CONSTITUENTS WERE FOUND DURING EDS ANALYSIS. AND IT WAS NOTED THAT VISUAL BUILD UP OF THE CORROSION PRODUCT WAS FOUND AT THE HOUSING/NEEDLE INTERFACE. THEREFORE, THE INVESTIGATION FOR THE REPORTED FOREIGN MATERIAL IS CONFIRMED AS THE RUST WAS FOUND DURING SEM ANALYSIS. THE DEFINITIVE ROOT FOR THE REPORTED FOREIGN MATERIAL 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. H10: D4 (EXPIRY DATE: 01/2023), G3. 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 A BIOPSY PROCEDURE, THE RUSTING WAS FOUND IN PACKAGE. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY CONTAMINATED BY RUST. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199050 MAXCORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. MC1610 REEP1407 00801741084447

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown