BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO 5F DUAL-LUMEN CATHETER BASIC TRAY

    MDR report key: 11933345 · Received June 3, 2021

    Report

    Report Number
    3006260740-2021-02151
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 14, 2021
    Report Date
    May 22, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REDR3501 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAS BEEN A NOTICEABLE INCREASE IN THE NUMBER OF 5FR DUAL LUMEN PICCS THAT ARE EXPERIENCING THROMBUS FORMATION AROUND THE CATHETER TIP. IT WAS REPORTED THAT THE THROMBUS IS FORMING PRIMARILY AROUND THE TIP OF THE CATHETER. INTERNAL COMMENTS: IT IS NOTED THAT LINES ARE TRIMMED, AND INSERTED TO THE CAJ. THE LOCAL POLICY IS NOT TO TRIM. MEDICAL INTERVENTION: YES. COMMENTS: PATIENT PUT ON ANTI-COAGULATION THERAPY. IT IS CURRENTLY UNKNOWN HOW MANY CATHETERS THIS HAS OCCURRED WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825468 POWERPICC SOLO 5F DUAL-LUMEN CATHETER BASIC TRAY CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REDR3501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention