BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET PLEURX CATHETER

    MDR report key: 19959798 · Received August 12, 2024

    Report

    Report Number
    19959798
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 18, 2024
    Report Date
    July 22, 2024
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING REMOVAL OF ROCKET PLEURX CATHETER, THE CATHETER FRACTURED AT THE LEVEL OF THE PROXIMAL CUFF. THE REMAINING CATHETER WAS REMOVED WITH TIP INTACT. FOLLOW UP CXR DEMONSTRATED COMPLETE REMOVAL. PRODUCT IS WITH MANAGER OF DEPARTMENT AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027739 ROCKET PLEURX CATHETER APPARATUS, SUCTION, PATIENT CARE DWM ROCKET MEDICAL PLC 499949

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male