BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20195402 · Received September 11, 2024

    Report

    Report Number
    3006260740-2024-05117
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    June 25, 2024
    Report Date
    May 27, 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
    SW
    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 THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    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.

    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 COMPLAINT OF A LEAKING VALVE WAS UNCONFIRMED BECAUSE THE PROBLEM COULD NOT BE REPRODUCED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4 FR SL POWERPICC SOLO CATHETER. THE UNIT WAS FUNCTIONALLY TESTED BY FLUSHING THE LUER WITH WATER USING A 12 ML LUER LOCK SYRINGE. DURING TESTING, NO LEAKS WERE IDENTIFIED. THE SOLO VALVE WAS SEPARATELY TESTED BY INFUSING THE CATHETER WITH WATER AND SUSPENDING THE CATHETER UPSIDE DOWN TO OBSERVE IF THE SOLO VALVE LEAKED; HOWEVER NO LEAKS WERE IDENTIFIED. BASED ON THE AVAILABLE EVIDENCE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED, LEAKAGE FROM THE VALVE. NO PATIENT HARM. INSERTED 230823. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED, LEAKAGE FROM THE VALVE. NO PATIENT HARM. INSERTED 230823. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623184 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 REGZ1017 00801741138973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other