BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC, 3CG

    MDR report key: 21766713 · Received April 3, 2025

    Report

    Report Number
    3006260740-2025-02021
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 4, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741139659
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    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

    ADDITIONAL INFORMATION RECEIVED 3/31: A NEW CATHETER WAS NOT PLACED. COMPLAINANT STATES THE EVENT CAUSED A CLINICALLY SIGNIFICANT DELAY IN TREATMENT BECAUSE IT OCCURRED DURING CHEMOTHERAPY INFUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED LEAKING NOTED FROM PICC SITE WHEN CHEMOTHERAPY BEING ADMINISTERED. INFUSION STOPPED AND LEAKING STILL VISIBLE. PICC REMOVED AND INTERNAL FRACTURE NOTED. PATIENT REVIEWED BY DOCTOR AND TREATED FOR AN EXTRAVASATION AS PER POLICY. FOLLOW UP ARRANGED FOR PATIENT THE NEXT WORKING DAY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847250 POWERPICC, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJS3894 00801741139659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R