BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC, 3CG

    MDR report key: 22248256 · Received June 17, 2025

    Report

    Report Number
    3006260740-2025-03976
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 1, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138966
    PMA / PMN Number
    K091324
    Adverse Event
    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 COMPLAINT OF INFECTION AT THE INSERTION SITE IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE PHOTOGRAPH OF A 4 FR SINGLE LUMEN POWERPICC WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED MILD REDNESS AND SWELLING WERE IN THE AREA SURROUNDING THE IMPLANTATION SITE. WHAT APPEARED TO BE YELLOW-CLEAR FLUID WAS OBSERVED AT THE INSERTION SITE. CONDENSATION WAS OBSERVED UNDER THE PLASTIC FILM DRESSING AT THE MOLDED JOINT. THE OBSERVATIONS INDICATE THE PATIENT LIKELY HAD AN INFECTION. THERE WAS NO SUPPORTING EVIDENCE WHICH DIRECTLY CONCLUDED THAT THE STERILITY OF THE BD DEVICE HAD BEEN COMPROMISED. PATIENT INFECTION CAN OCCUR DUE TO CONTAMINATION OF THE PRODUCT AND/OR INSERTION SITE AT ANY POINT PRIOR TO, DURING, OR FOLLOWING INSERTION AND, CONSEQUENTLY, IDENTIFYING THE SPECIFIC SOURCE OF CONTAMINATION COULD NOT BE INDEPENDENTLY DETERMINED BY BD. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT DEVELOPED A DISCHARGE AND LYMPHEDEMA ON THE ARM CARRYING THE PICC. PICC CULTURED POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE DEVICE WAS REMOVED AND DISCARDED. A NEW PICC WAS INSERTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. PATIENT RETURNED HOME ON (B)(6) 2025. CUSTOMER STATES THE DISCHARGE WAS NOT RELATED TO INFUSIONS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650022 POWERPICC, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJS1322 00801741138966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention