BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET IPC INSERTION SET

    MDR report key: 13666270 · Received March 4, 2022

    Report

    Report Number
    13666270
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 23, 2022
    Report Date
    February 23, 2022
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    DWM
    UDI-DI
    05055270965783
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ADULT MALE WITH HISTORY OF DIABETES MELLITUS (DM), METASTATIC PANCREATIC CA AND RESENT SHORTNESS OF BREATH. PROCEDURE: PLACEMENT OF LEFT PLEURAL DRAINAGE CATHETER WITH ULTRASOUND GUIDANCE. DURING THE PROCEDURE, THE TUNNELER BROKE WHEN TRYING TO TUNNEL THROUGH THE PLEURAL SPACE. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR ROCKET IPC INSERTION SET, ROCKET (PER SITE REPORTER). WILL OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532864 ROCKET IPC INSERTION SET APPARATUS, SUCTION, PATIENT CARE DWM ROCKET MEDICAL PLC R51400-16-00 489422 05055270965783

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA Male