BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER W/ SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY

    MDR report key: 20855243 · Received December 5, 2024

    Report

    Report Number
    3006260740-2024-07240
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 7, 2024
    Report Date
    May 1, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138973
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INITIAL MEDWATCH REPORT WAS SUBMITTED, UPON FURTHER REVIEW IT WAS FOUND THAT THIS MEDWATCH REPORT 3006260740-2024-07240 IS A DUPLICATE FILE AND HAS BEEN VOIDED. THE ORIGINAL EVENT WAS SUBMITTED ON MEDWATCH REPORT 3006260740-2024-07216.

    Description of Event or Problem · 0

    IT WAS REPORTED LEAK OCCURRED OUTSIDE THE BODY. PICC DRESSING NOTICED TO BE WET POST TREATMENT. TREATED FOR POSSIBLE EXTRAVASATION. PATIENT CONTINUES TO REPORT NO SYMPTOMS OF SAME. INSERTION DATE WAS (B)(6) 2024. 122 DAYS IN USE. EXIT SITE MARKING WAS 3CM. USED FOR CT WITH CONTRAST ON (B)(6) 2024 AND (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471751 POWERPICC SOLO CATHETER W/ SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REHZ0711 00801741138973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other