BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCKET MEDICAL

    MDR report key: 23991056 · Received January 7, 2026

    Report

    Report Number
    3002808026-2026-00001
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 7, 2026
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFORMATION SUPPLIED BY CUSTOMER: WHAT FAILED? LEAKAGE OR AIR INTAKE AT A PLUG THAT SHOULD NORMALLY BE OCCLUSIVE. HOW DID IT FAIL? DURING A PROCEDURE SEQUENCE OF EVENTS? PATIENT ARRIVING AT THE PULMONARY WARD FOR DRAINAGE OF PLEURAL EFFUSION. THE INTERN, ASSISTED BY THE PULMONOLOGIST, PERFORMS THE DRAINAGE PUNCTURE USING THE MEDICAL DEVICE USED IN THE DEPARTMENT, NAMELY AN 8FR CATHETER FROM ROCKET MEDICAL. THE PROCEDURE PROCEEDS NORMALLY, AND THE DRAIN IS IN PLACE IN THE PLEURA. AS DRAINAGE BEGINS, WE NOTICE A LEAK OR AIR INTAKE AT A PLUG THAT SHOULD NORMALLY BE OCCLUSIVE. THE DRAINAGE CONTINUED AND WAS COMPLETED WITHOUT CONSEQUENCE, BUT THERE COULD HAVE BEEN A PNEUMOTHORAX OR INCREASED PAIN FOR THE PATIENT. THE DOCTOR REMOVES THIS PLUG AND APPLIES HIS FINGER TO THE OPENING TO ENSURE IT IS SEALED (HYGIENE RULES ARE OBSERVED BY WEARING STERILE GLOVES). DRAINAGE CAN THEN CONTINUE SAFELY. IT IS A RECURRING PROBLEM WITH THE CATHETER DEVICE. THIS OCCURS ONCE OR SEVERAL TIMES A YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49229 ROCKET MEDICAL ROCKET 8FG THORACENTESIS SET WITH 8FG SAFETY NEEDLE MOUNTED CATHETER GBX ROCKET MEDICAL PLC 504575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other