BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLVE® LOCKING DRAINAGE.CATHETER.10F.PIGTAIL.MARKER BAND.0.038" (0.97 MM)

    MDR report key: 22787641 · Received August 12, 2025

    Report

    Report Number
    1721504-2025-00240
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 23, 2025
    Report Date
    September 9, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    GXB
    UDI-DI
    00884450580615
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND CORRECTIVE ACTIONS ARE TAKEN AS WARRANTED. TREND DATA WILL BE USED TO MONITOR COMPLAINTS AND THE PERFORMANCE OF PRODUCTION PROCESSES AND QUICKLY ADDRESS ANY DEVIATIONS FROM ESTABLISHED STANDARDS.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    CUSTOMER REPORTS WHILE EXCHANGING A MULTIPURPOSE DRAIN THAT HAD A CRACK IN THE CATHETER, THE CATHETER FELL APART AT THE RADIOPAQUE MARKER LEAVING PART OF THE CATHETER IN THE PATIENT. THEY WERE ABLE TO EVENTUALLY GET THE REST OF THE CATHETER OUT BUT ON INSPECTION IT APPEARS IT WAS ALSO COMING APART ON THE DISTAL SIDE OF THE MARKER AS WELL. NO ADDITIONAL PATIENT DETAILS WERE PROVIDED AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563096 RESOLVE® LOCKING DRAINAGE.CATHETER.10F.PIGTAIL.MARKER BAND.0.038" (0.97 MM) CATHETER, IRRIGATION GXB MERIT MEDICAL SYSTEMS INC. 00884450580615 I3076036 00884450580615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention