BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC, 3CG

    MDR report key: 22071723 · Received May 22, 2025

    Report

    Report Number
    3006260740-2025-03308
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    May 5, 2025
    Report Date
    July 3, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741034459
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. 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. 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.

    Additional Manufacturer Narrative · 0

    INITIAL MEDWATCH REPORT WAS SUBMITTED, UPON FURTHER REVIEW IT WAS FOUND THAT THIS MEDWATCH REPORT 3006260740-2025-03308 IS A DUPLICATE FILE AND HAS BEEN VOIDED. THE ORIGINAL EVENT WAS SUBMITTED ON MEDWATCH REPORT 3006260740-2025-03263.

    Description of Event or Problem · 0

    IT WAS REPORTED; LEAKING LINE OCCURRED OVER THE WEEKEND. THE EXTERNAL LENGTH OF THE LINE HAD A FRACTURE/HOLE AND WAS CONTINUOUSLY LEAKING (A MORPHINE DRIP WAS RUNNING). NURSING STAFF HAS ¿PLUGGED¿ THE HOLE BY WRAPPING A TEGADERM AROUND IT. THE NEGATIVE OUTCOME FOR THIS INCIDENT WAS THE DELAY IN CARE. PATIENT¿S CONTINUOUS MORPHINE DRIP HAD TO BE HELD FROM THE TIME THE LINE WAS REMOVED UNTIL THE NEW LINE WAS INSERTED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366165 POWERPICC, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJY0553 00801741034459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention