BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOD ULTRASOUND GUIDED BIOPSY NE

    MDR report key: 20910646 · Received December 12, 2024

    Report

    Report Number
    3005099803-2024-06338
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    00191506020729
    PMA / PMN Number
    K221340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE) IS EOQ, ITX. BLOCK H6: DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INOD ULTRASOUND GUIDED BIOPSY NEEDLE WAS TO BE USE IN A INOD NAVIGATIONAL BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE PACKAGE WAS FOUND PARTIALLY OPENED. THEY COULDN'T USE THE DEVICE AND COMPLETED THE PROCEDURE BY OPENING A NEW ONE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203835 INOD ULTRASOUND GUIDED BIOPSY NE BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00502060 0034002622 00191506020729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown