BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5FX20CM TPL LMN CATH

    MDR report key: 23715595 · Received December 4, 2025

    Report

    Report Number
    2518902-2025-00071
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    January 8, 2025
    Report Date
    December 9, 2025
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    MPB
    UDI-DI
    00884908060867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT NUMBER PROVIDED. THEIR INVESTIGATION REVEALED THE DEVICE WAS MANUFACTURED, ASSEMBLED, AND INSPECTED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE PROCEDURE FOR ATTACHING THE SUTURE WING CLEARLY IDENTIFIES THE PROCESS. THE OPERATOR ATTACHES THE SUTURE WING BY PUSHING THE WING UP ONTO THE HUB UNTIL IT IS PROPERLY SEATED IN THE CORRECT POSITION ON THE HUB AND ROTATES THE WING A FEW TIMES WHICH WOULD INDICATE CORRECT ASSEMBLY. WITHOUT AN EVALUATION OF THE DEVICE THE COMPLAINT CANNOT BE CONFIRMED, AND A ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THE DEVICE WAS SUBJECTED TO FORCES GREATER THAN THAT WHICH IT IS DESIGNED TO WITHSTAND.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE DEVICE WAS FOUND NEXT TO THE PATIENT WITH THE SECURING PART STILL ATTACHED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979254 11.5FX20CM TPL LMN CATH TRI-FLOW CATHETER MPB MEDICAL COMPONENTS, INC. XTP3118MTE MRCP960 00884908060867

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention