BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19316130 · Received May 14, 2024

    Report

    Report Number
    3006260740-2024-02337
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 17, 2024
    Report Date
    April 29, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. H3 OTHER TEXT : DEVICE NOT RECEIVED

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿INSERTED (B)(6) 2024, SECUREMENT STATLOCK 240417, WHEN FLUSHING NACL. THEY CAN SEE LEAKAGE UNDER THE DRESSING, PICC LINE IS REMOVED AND HOLE IN THE CATHETER AT THE 2CM MARK ARE FOUND.¿ NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2024: IT WAS REPORTED, ¿OTHER THAN PICC LINE REMOVAL, THERE WAS NO PATIENT IMPACT AND NO EXPOSURE TO BLOOD OR BODILY FLUIDS. THE PRODUCT WAS USED WITH CYTOTOXIC MEDICATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359481 POWERPICC SOLO CATHETER WITH 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 REHP3701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other