BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO2

    MDR report key: 23772608 · Received December 10, 2025

    Report

    Report Number
    3006260740-2025-09527
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 15, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138973
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    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 THE VALVE WAS NON-FUNCTIONAL, ACTIVE VENOUS RETURN AFTER TWO PULSED RINSES WITH 0.9% SALINE SOLUTION BEFORE INSERTING THE CAP. THE PICCS LINE WAS NEW AND HAD JUST BEEN INSERTED INTO THE PATIENT. NO HARM WAS CAUSED TO PATIENT OR PICC PLACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858914 POWERPICC SOLO2 PERIPHERALLY INSERTED CENTRAL CATHETER LJS C.R. BARD, INC. (BASD) -3006260740 N/A REKS3352 00801741138973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other