BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17725870 · Received September 11, 2023

    Report

    Report Number
    3006260740-2023-04021
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    July 7, 2023
    Report Date
    September 15, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    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.

    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 RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED RUPTURE OCCURRED IN DEVICE IMPLANTED A FEW MONTHS AGO. UPDATE RECEIVED ((B)(6) 2023): IMPLANTATION OCCURRED ON (B)(6) 2023 POWER PICC CATHETER ONLY LOT REGX 1782 SACDENZA (B)(6) 2024 SUBCUTANEOUS ANCHOR FIXATION SYSTEM, MALFUNCTIONING SINCE (B)(6) 2023 AND REMOVED ON (B)(6) 2023. UPON REMOVAL, IT WAS FOUND TO BE BROKEN IN TWO PLACES (AT 6 AND 10 CM). THE PATIENT HAS NEVER USED THE DEVICE FOR ANY THERAPY OR INFUSION, NOR FOR BLOOD SAMPLES, EXCEPT FOR WEEKLY IRRIGATION ACCORDING TO COMPANY PROTOCOL. OF COURSE THE PATIENT WAS NOT HARMED IN ANY WAY. DEVICE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED RUPTURE OCCURRED IN DEVICE IMPLANTED A FEW MONTHS AGO. UPDATE RECEIVED (29/AUG/2023): IMPLANTATION OCCURRED ON (B)(6) 2023 POWER PICC CATHETER ONLY LOT REGX 1782 SACDENZA (B)(6) 2024 (SAME LOT AS PR#7935593) SUBCUTANEOUS ANCHOR FIXATION SYSTEM, MALFUNCTIONING SINCE (B)(6) 2023 AND REMOVED ON (B)(6) 2023. UPON REMOVAL, IT WAS FOUND TO BE BROKEN IN TWO PLACES (AT 6 AND 10 CM). THE PATIENT HAS NEVER USED THE DEVICE FOR ANY THERAPY OR INFUSION, NOR FOR BLOOD SAMPLES, EXCEPT FOR WEEKLY IRRIGATION ACCORDING TO COMPANY PROTOCOL. OF COURSE THE PATIENT WAS NOT HARMED IN ANY WAY. DEVICE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146229 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 REGX1782

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other