BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCEL®

    MDR report key: 21546014 · Received March 7, 2025

    Report

    Report Number
    21546014
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 20, 2025
    Report Date
    February 28, 2025
    Manufacturer
    B. BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CAME TO IR FOR A LEAKING DRAINAGE TUBE. WAS FOUND THAT THE TUBE HUB WAS CRACKED AND CAUSING THE LEAKING. RESULTED IN PATIENT NEEDING A TUBE CHANGE SOONER THAN ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486836 ACCEL® STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE B. BRAUN INTERVENTIONAL SYSTEMS, INC 613911

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Male Other