BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET

    MDR report key: 14416047 · Received May 17, 2022

    Report

    Report Number
    14416047
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    May 10, 2022
    Report Date
    May 12, 2022
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    PNG
    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

    ELDERLY MALE WITH HISTORY OF CORONARY DISEASE, CONGESTIVE HEART FAILURE, DECOMPENSATED SEVERE CONGESTIVE HEART FAILURE AND RIGHT-SIDED PLEURX CATHETER. CATHETER WAS NOT DRAINING WITH THE FIRST BOTTLE, NOTICED THAT THE BELLOW WAS OPEN, AND NO DRAINAGE WAS FILLING INTO BOTTLE. A 2ND BOTTLE OPENED, AND IT TOO HAD THE BELLOW OPEN. THE 3RD BOTTLE USED WORKED EFFECTIVELY. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR IPC 1000CC BOTTLE & DRESSING PACK, (BRAND NOT PROVIDED) (PER SITE REPORTER). WILL OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787691 ROCKET IPC 1000CC BOTTLE & DRESSING PACK PNG ROCKET MEDICAL PLC R51411 493750

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male