BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20419097 · Received October 10, 2024

    Report

    Report Number
    3006260740-2024-05849
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 11, 2024
    Report Date
    January 27, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 COMPLAINT OF A LEAK IS CONFIRMED BUT THE CAUSE IS UNKNOWN. THE PRODUCT RETURNED FOR EVALUATION WAS A 4FR SL POWERPICC SOLO CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A KINK IMPRESSION WITH A LONGITUDINAL SPLIT WAS OBSERVED BETWEEN THE 15 CM AND 16 CM DEPTH MARKERS ON THE CATHETER BODY. NO SPECIFIC EVIDENCE WAS SEEN DURING THE INVESTIGATION WHICH SUPPORTED A SPECIFIC ROOT CAUSE FOR THIS EVENT. THE DAMAGE LOCATION SUGGESTED THAT CATHETER SECUREMENT, ACCESS, AND/OR MAINTENANCE TECHNIQUES MAY HAVE CONTRIBUTED. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONCOLOGY PATIENT RECEIVING 3 CONSECUTIVE DAYS OF TREATMENT. DAY 3 WHEN FLUSHED PICC NOTED IMMEDIATE LEAKING AT INSERTION SITE. NO PROBLEM PREVIOUS DAYS. REPEAT FLUSH, SAME OCCURRING. PICC REMOVED. HOLE NOTED IN CATHETER BETWEEN 5-6 CM MARK. CHEMO DELAY. PERIPHERAL ACCESS ESTABLISHED. PICC INITIALLY INSERTED ON (B)(6) 2024 AND NO ISSUES NOTED. R BASILIC 36/40 = OAJ. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONCOLOGY PATIENT RECEIVING 3 CONSECUTIVE DAYS OF TREATMENT. DAY 3 WHEN FLUSHED PICC NOTED IMMEDIATE LEAKING AT INSERTION SITE. NO PROBLEM PREVIOUS DAYS. REPEAT FLUSH, SAME OCCURRING. PICC REMOVED. HOLE NOTED IN CATHETER BETWEEN 5-6 CM MARK. CHEMO DELAY. PERIPHERAL ACCESS ESTABLISHED. PICC INITIALLY INSERTED ON (B)(6) 2024 AND NO ISSUES NOTED. R BASILIC 36/40 = OAJ. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933348 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 REJQ1580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other