BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO2

    MDR report key: 25044827 · Received April 30, 2026

    Report

    Report Number
    3006260740-2026-03043
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741034527
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 THAT REMOVAL OF PICC IN MSE DUE TO COMPLAINT OF PAIN DURING INFUSION OF MEDICATION. AFTER REMOVAL, WHEN INJECTING SF 0.9% INTO THE CATHETER, A HOLE WAS OBSERVED IN THE STRUCTURE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262971 POWERPICC SOLO2 PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REKR0104 00801741034527

    Patients

    Seq Age Sex Outcome Treatment
    1