BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC HF CATHETER

    MDR report key: 22726656 · Received August 6, 2025

    Report

    Report Number
    22726656
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENTS IN IMAGING RECOVERY UNDERGO A PROCEDURE WHERE THE RNS AND OTHER CAREGIVERS USE A BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET REF 1385118Q, IH #32037879. THERE IS A BAD LOT # REJU3499. IT LEAKS DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288376 POWERPICC HF CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC. 1385118Q REJU3499

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown