BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORACIC CATHETER STRAIGHT FR 24

    MDR report key: 24921846 · Received April 20, 2026

    Report

    Report Number
    3013058659-2026-00001
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 17, 2026
    Report Date
    March 18, 2026
    Manufacturer
    REDAX S.P.A.
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF THE INVESTIGATION AND GIVEN THAT NO INFORMATION WAS PROVIDED REGARDING THE SPECIFIC LOT ASSOCIATED WITH THE REPORTED EVENT, A REVIEW WAS CONDUCTED OF THE PRODUCTION RECORDS FOR THE LOTS CURRENTLY HELD IN OUR WAREHOUSE, TOGETHER WITH THE RELEVANT QUALITY CONTROL AND RELEASE DOCUMENTATION. NO DISCREPANCIES OR ABNORMALITIES WERE IDENTIFIED DURING THIS REVIEW. SALES VOLUME DATA INDICATE THAT (B)(4) UNITS WERE DISTRIBUTED IN 2024 AND (B)(4) UNITS IN 2025. TO DATE, NO SIMILAR COMPLAINTS OR ADVERSE EVENT REPORTS HAVE BEEN RECEIVED FROM OTHER COUNTRIES OR MARKETS. A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORDS (DHR), QUALITY CONTROL DOCUMENTATION, AND TESTING RECORDS WAS PERFORMED. THE REVIEW CONFIRMED THAT THE PRODUCTS WERE MANUFACTURED AND RELEASED FOLLOWING COMPLETION OF ALL REQUIRED INSPECTIONS AND TESTS. ALL ACCEPTANCE CRITERIA WERE MET, AND THE PRODUCTS WERE FOUND TO BE IN COMPLIANCE WITH APPLICABLE SPECIFICATIONS. NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED AT ANY STAGE OF THE MANUFACTURING, TESTING, OR RELEASE PROCESSES. NO PRODUCT-RELATED NONCONFORMITIES WERE IDENTIFIED. THE PRODUCTS WERE MANUFACTURED AND CONTROLLED IN ACCORDANCE WITH THE APPLICABLE REFERENCE STANDARD EN (B)(4). BASED ON THE INFORMATION REVIEWED AND THE RESULTS OF THE INVESTIGATION, THERE IS NO EVIDENCE TO INDICATE A SYSTEMIC ISSUE OR A MANUFACTURING- OR QUALITY-RELATED ROOT CAUSE. AT THIS TIME, THE REPORTED EVENT APPEARS TO BE ISOLATED.

    Description of Event or Problem · 0

    DURING DRAIN REMOVAL, THE TUBE HAS BROKEN. THE DRAIN WAS KEPT IN PLACE LESS THAN 24 HOURS. THE PATIENT HAD TO COME IN FOR ANOTHER SURGERY FOR REMOVAL OF RETAINED CHEST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983160 THORACIC CATHETER STRAIGHT FR 24 THORACIC CATHETER STRAIGHT FR 24, PRODUCT CODE: GBX GBX REDAX S.P.A. 20824 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization