BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC, 3CG

    MDR report key: 22170561 · Received June 9, 2025

    Report

    Report Number
    3006260740-2025-03706
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 21, 2025
    Report Date
    May 26, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138966
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS.

    Description of Event or Problem · 0

    IT WAS REPORTED TOTAL RUPTURE OF THE DEVICE WITH EMBOLISATION OF THE DISTAL STUMP IS REPORTED. CATHETER MALFUNCTION AND LEAKAGE OF INFUSED SUBSTANCE IS REPORTED. PERFORMING CHEST X-RAY SHOWS TOTAL RUPTURE OF THE CATHETER IN THE INTRAVASCULAR TRACT WITH EMBOLISATION OF THE DISTAL STUMP. THE EMBOLIZED STUMP WAS RETRIEVED USING INTERVENTIONAL RADIOLOGY PROCEDURES. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333096 POWERPICC, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJS4771 00801741138966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention