BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA

    MDR report key: 19234427 · Received May 2, 2024

    Report

    Report Number
    2124215-2024-24129
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MFR: THE DEVICE WAS NOT RETURNED. HOWEVER, A PHOTO WAS PROVIDED FROM THE HEALTHCARE FACILITY. IT SHOWS THAT THE SUTURE SEPARATES FROM THE KEY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THREAD THAT GOES INSIDE THE CATHETER WAS LOOSE. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR PERCUTANEOUS NEPHROSTOMY. HOWEVER, WHEN THE DEVICE WAS UNPACKED, IT WAS NOTED THAT THE THREAD THAT GOES INSIDE THE CATHETER WAS LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THREAD THAT GOES INSIDE THE CATHETER WAS LOOSE. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR PERCUTANEOUS NEPHROSTOMY. HOWEVER, WHEN THE DEVICE WAS UNPACKED, IT WAS NOTED THAT THE THREAD THAT GOES INSIDE THE CATHETER WAS LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411351 FLEXIMA TUBE, DRAINAGE, SUPRAPUBIC GBO BOSTON SCIENTIFIC CORPORATION 32615 0031710591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown