BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEBACK CROSSING CATHETER

    MDR report key: 24387020 · Received February 19, 2026

    Report

    Report Number
    3009128730-2026-00001
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 21, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BENTLEY INNOMED GMBH
    Product Code
    PDU
    UDI-DI
    04260279096487
    PMA / PMN Number
    K211802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE DISTRIBUTOR TO BENTLEY: "PER THE REP: YESTERDAY, WHILE PREPARING FOR A CASE, I OPENED THE PACKAGING OF A BEBACK CATHETER AND OBSERVED THAT THE NEEDLE WAS ALREADY EXTENDED FROM THE CATHETER. ADDITIONALLY, THE PLASTIC BARRIER OF THE INNER PACKAGING APPEARED COMPROMISED, WITH VISIBLE HOLES. PLEASE NOTE THE FOLLOWING: THE DEVICE WAS NOT FULLY OPENED. IT WAS NOT PROVIDED TO HOSPITAL STAFF. NO HARM OCCURRED TO THE PATIENT." BASED ON THIS INFORMATION OUR CURRENT UNDERSTANDING IS THAT THE STERILE BARRIER OF THE DEVICE WAS COMPROMISED, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY ACCORDING TO THE RISK ASSESSMENT OF THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490820 BEBACK CROSSING CATHETER CROSSING CATHETER PDU BENTLEY INNOMED GMBH FPP600L242 04260279096487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown