BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G 8CM STILETTO EXTENDED DWELL CATHETER

    MDR report key: 23782325 · Received December 11, 2025

    Report

    Report Number
    23782325
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 29, 2025
    Manufacturer
    AVIA VASCULAR
    Product Code
    PND
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    END OF CATHETER LOOKED LIKE A Y WITH NEEDLE HAVING POKED THROUGH. MANUFACTURER RESPONSE FOR MIDLINE CATHETER, 20G 8CM STILETTO EXTENDED DWELL CATHETER (PER SITE REPORTER). WAITING FOR THEIR RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858022 20G 8CM STILETTO EXTENDED DWELL CATHETER MIDLINE CATHETER PND AVIA VASCULAR PIP200000 BSLC8057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male