BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRAL DRAIN FR 15

    MDR report key: 21924364 · Received April 29, 2025

    Report

    Report Number
    3013058659-2025-00001
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    February 13, 2025
    Report Date
    April 15, 2025
    Manufacturer
    REDAX S.P.A.
    Product Code
    GBX
    UDI-DI
    08034139294940
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REDAX RECEIVED THE ANSWERS TO THE QUESTIONS ADDRESSED TO THE USER, RELATING TO THE TIME THE DEVICES REMAINED ON THE PATIENT (FEW DAYS) AND THE PHOTO SHOWING THE BREAKAGE. WE VERIFIED THE PICTURES. IT IS NOT POSSIBLE TO HAVE PARTICULAR INDICATIONS ABOUT THE BREAKING OF THE DRAIN. AS PART OF OUR INVESTIGATION, WE HAVE VERIFIED THE PRODUCTION LOT RECORD AND ALL QUALITY CONTROL DOCUMENTATION. NO ANOMALIES WERE DETECTED. BASED ON THE ANALYSIS OF THE PRODUCTION BATCH RECORD (DHR), AS WELL AS THE QUALITY CONTROL AND TESTING RECORDS, THE PRODUCT HAS BEEN RELEASED AFTER A FULL ANALYSIS AND IT IS IN COMPLIANCE WITH THE SPECIFICATIONS. NO DEVIATION ARE OBSERVED AT ANY STAGE. NO PRODUCT NONCOMPLIANCE WAS FOUND. FURTHERMORE, IT IS NOTED THAT THE TENSILE TESTS CONDUCTED INTERNALLY AND ASSOCIATED WITH THE PRODUCTION BATCH GAVE EVIDENCE OF COMPLIANCE WITH THE INTERNAL PROCEDURE AND THE STANDARD EN ISO 20697. IN 2023 AND 2024 WE SOLD RESPECTIVELY (B)(4) PIECES. NO COMPLAINTS WERE RECEIVED FROM OTHER COUNTRIES FOR SIMILAR ISSUES. WE CAN REASONABLY SAY THAT THIS IS AN ISOLATED CASE.

    Description of Event or Problem · 0

    DURING THE DRAIN REMOVAL, THE TUBE HAS BROKEN. THE DRAIN WAS KEPT IN PLACE FOR 3 DAYS. THE DRAIN WAS IN PLACE WITH A HOLDING SUTURE. THE BREAK IS BELOW WHERE THE HOLDING SUTURE WAS PLACED. THE PATIENT REQUIRED FURTHER SURGERY TO REMOVE THE RETAINED PORTION OF THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227207 SPIRAL DRAIN FR 15 ROUND FLUTED DRAIN FR 15, CODE: GBX GBX REDAX S.P.A. 24603 F2406024 08034139294940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization