BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC, 3CG

    MDR report key: 22745446 · Received August 7, 2025

    Report

    Report Number
    3006260740-2025-05645
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 29, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138980
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 COMPLAINT OF A BROKEN PICC IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. TWO PHOTOGRAPHS OF A POWERPICC WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPHS SHOWED A BREAK IN THE CATHETER SHAFT NEAR THE 26CM DEPTH MARKING. THE CATHETER SHAFT APPEARED TO RADIATE OUTWARD AT THE BREAK SITE. NO FURTHER DETAILS OF THE DAMAGE WERE DISCERNED IN THE PHOTOGRAPHS. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED PHOTOGRAPHS OF THE SAMPLE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE OF THE BREAK. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    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 THE EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER; THE DATE REFLECTED IN THIS REPORT IS THE DATE ON WHICH BD BECAME AWARE OF THE EVENT. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IT WILL BE EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PART OF THE CATHETER BROKE OFF DURING A PROCEDURE. AS A RESULT, PART OF THE CATHETER GOT STUCK IN THE PATIENT'S RIGHT AORTIC ARTERY CAVITY, REQUIRING A NEW PROCEDURE TO REMOVE THE MATERIAL. THE PATIENT UNDERWENT THE PROCEDURE WITH THE USE OF THE CATHETER AND ONLY RETURNED TO THE HOSPITAL THE FOLLOWING MONTH WHERE HE DISCOVERED THE OCCURRENCE FROM AN EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2862048 POWERPICC, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJX3316 00801741138980

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention