BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO2

    MDR report key: 24677165 · Received March 24, 2026

    Report

    Report Number
    3006260740-2026-01917
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 7, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138973
    PMA / PMN Number
    UNK
    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. 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. THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INFUSION OF BENDAMUSTINE, THE PATIENT CALLS FOR DISCOMFORT IN THE ARM (SITE OF PICC), SO THE INFUSION RATE IS REDUCED. AT THE END, THE NURSES OBSERVED EDEMA IN THE RIGHT ARM WITH SLIGHT PAIN IN PLACE, NOT ERYTHEMA (GRADE 1 EXTRAVASATION). WHEN SAMPLING/WASHING, YOU CAN SEE DRIPPING FROM THE INSERTION AS IF BY CRACKING THE PICC. AS PER IOG, ICE IS PLACED AND THEN THE DEVICE IS REMOVED. CONTACT THE VULNOLOGY SERVICE, IN CONSIDERATION OF IRRITANT AGENT (BENDAMUSTINE), DO NOT INDICATE OTHER PROCEDURES EXCEPT 24-HOUR CONTROL FOR ANY BANDAGING. TOPICAL SYMPTOMATIC THERAPY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275289 POWERPICC SOLO2 PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 NA REJY0414 00801741138973

    Patients

    Seq Age Sex Outcome Treatment
    1