BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCKET IPC INSERTION SET PLEUREX CATHETER

    MDR report key: 7969059 · Received October 15, 2018

    Report

    Report Number
    MW5080573
    Event Type
    Injury
    Date Received
    October 15, 2018
    Date of Event
    September 20, 2018
    Report Date
    October 11, 2018
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTS FOR REMOVAL OF TUNNELLED LEFT ROCKET MEDICAL PLEURAL DRAINAGE CATHETER. IN PROCESS OF REMOVING CATHETER, IT WAS NOTED THAT THE CATHETER WAS DISTAL END NEAR THE CUFF WITH CONTINUED CHALLENGES TO REMOVE CATHETER. THIS DIFFICULTY PROMPTED A CUT DOWN TO BE MADE TO EXPOSE THE CUFF, SO THE CATHETER COULD BE MOVED. SITE SUTURED AND GLUED WITH DSD. THE CATHETER SEQUESTERED. (B)(6) 2018 - INSERTION OF PLEUREX CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804734 ROCKET IPC INSERTION SET PLEUREX CATHETER APPARATUS, SUCTION, PATIENT CARE DWM ROCKET MEDICAL PLC 475988

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention