BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC

    MDR report key: 25111270 · Received May 7, 2026

    Report

    Report Number
    3006260740-2026-03220
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 27, 2026
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741155147
    PMA / PMN Number
    K070996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT CAME IN WITH PRESENT ON ADMISSION PICC. INSERTED ON (B)(6) 2026 ORIGINALLY. VASCULAR ACCESS TEAM CALLED STATING PICC WAS LEAKING, EVALUATED AND CRACK ON SIDE OF LINE/HUB BY WINGS NOTED. PATIENT HAD LINE D/CD. NO PATIENT IMPACT OF DELAY IN CARE. TREATMENT WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8807 POWERPICC PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 NA UNKNOWN 00801741155147

    Patients

    Seq Age Sex Outcome Treatment
    1