BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRK-1

    MDR report key: 18621476 · Received February 1, 2024

    Report

    Report Number
    18621476
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 4, 2024
    Manufacturer
    ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE TRANSSEPTAL NEEDLE WAS BENT IN THE PACKAGE. THE PRODUCT WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. ST. JUDE BRK-1 NEEDLE, REF: 407201, LOT: 9153402, CLINICAL SITE NOTIFIED MFG REP DIRECTLY. MANUFACTURER RESPONSE FOR TRANSSEPTAL NEEDLE, ST. JUDE BRK-1 NEEDLE TRANSSEPTAL NEEDLE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374475 BRK-1 TROCAR DRC ST. JUDE MEDICAL CARDIOVASCULAR DIVISION 407201 9153402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown