BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN TRIFUSION TRIPLE-LUMEN LONG-TERM CENTRAL VENOUS CATHETER

    MDR report key: 17912320 · Received October 11, 2023

    Report

    Report Number
    17912320
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    May 30, 2023
    Report Date
    August 14, 2023
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DR. REMOVED A TRIALYSIS TUNNELED CATHETER ON [REDACTED DATE]. THE CATHETER HAS A CUFF ON IT THAT THE TISSUE GROWS INTO TO PREVENT INFECTION AND DISLODGEMENT. THE CUFF WAS NOT ON THE CATHETER WHEN IT WAS REMOVED. DR. INFORMED THE PATIENT THAT THE CUFF WAS INSIDE THE TUNNEL, THE PATIENT HAS ELECTED TO COME BACK AND HAVE THE CUFF REMOVED FROM THE TUNNEL. RISK AND REGULATORY AT YNHHS DETERMINED: BASED ON THE INFORMATION PROVIDED, THIS DOES NOT MEET DPH REPORTING REQUIREMENTS UNDER NQF 1D OR NQF 2B, AS THERE WAS NO SERIOUS HARM/INJURY TO THE PATIENT, AND THE PATIENT ELECTED TO HAVE A SECONDARY PROCEDURE TO REMOVE THE CUFF, WHICH WILL NOT REQUIRE GENERAL ANESTHESIA. THIS DOES NOT MEET TJC REQUIREMENTS FOR UNINTENDED RETAINED FOREIGN OBJECT, AS YOU INDICATED IN YOUR NOTE THAT THE PIECE WAS KNOWINGLY LEFT BEHIND. MFG NOT NOTIFIED BY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179521 HICKMAN TRIFUSION TRIPLE-LUMEN LONG-TERM CENTRAL VENOUS CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. 0609190 REGT4603

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown