BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCKET

    MDR report key: 23778491 · Received December 11, 2025

    Report

    Report Number
    3002808026-2025-00001
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    GBX
    Removal / Correction Number
    9610632-11/14/25-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ED PHYSICIAN DID NOT SUTURE THE DRAIN, WHICH HAS HAPPENED BEFORE, AS THEY JUST FORGOT. DISCUSSED TO ADD SUTURING TO STICKER ON 12F SELDINGER PACK, OR EVEN INTRODUCE A SUTURE IN THE PACK. PATIENT WAS NOT PLEURODESED, AS DRAIN FELL OUT, IT WAS FOR SECONDARY PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526541 ROCKET R54544-12-SG ROCKET 12FG SELDINGER CATHETER WITH SAFETY GUARD GBX ROCKET MEDICAL PLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention