BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE

    MDR report key: 21932467 · Received April 30, 2025

    Report

    Report Number
    2020394-2025-00635
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    July 31, 2024
    Report Date
    April 23, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741084478
    PMA / PMN Number
    K133948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: A SEALED MAXCORE CORE DISPOSABLE BIOPSY INSTRUMENT WAS RECEIVED FOR EVALUATION. DURING VISUAL EVALUATION, IT APPEARED THE PLASTIC OUTER PACKAGING WAS CRACKED NEAR THE DISTAL TIP OF THE NEEDLE. PLASTIC PIECES WERE NOTED TO BE INSIDE THE SEALED PRODUCT PACKAGING. THE PLASTIC PACKAGING WAS NOTED TO BE BROKEN AT THE DISTAL END WITH THE TRAY STILL ATTACHED TO THE LABEL. CRACKS WERE NOTED TO THE PLASTIC WHERE THE BREAK WAS LOCATED. ADHESIVE WAS NOTED TO THE LABEL. DUE TO THE NATURE OF THE COMPLAINT, NO FUNCTIONAL TESTING WAS PERFORMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED PACKAGING PROBLEM (TEAR, RIP OR HOLE IN DEVICE PACKAGING) AS THE PLASTIC PACKAGING WAS NOTED TO BE BROKEN AT THE DISTAL END. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PACKAGING PROBLEM (TEAR, RIP OR HOLE IN DEVICE PACKAGING) COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. 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 PLASTIC PACKAGING WAS ALLEGEDLY HAD BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580732 MAXCORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REHV4205 00801741084478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown