BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC, 3CG

    MDR report key: 22414054 · Received July 7, 2025

    Report

    Report Number
    3006260740-2025-04575
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 5, 2025
    Report Date
    August 20, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138966
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 IT 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 DATE OF AWARENESS WAS CORRECTED TO JUNE 26, 2025, AS THIS IS THE DATE THE BD EMPLOYEE BECAME AWARE OF THE REPORTED EVENT. THIS SUPPLEMENTAL REPORT IS TO CORRECT THE PREVIOUSLY REPORTED DATE OF AWARENESS, AND THE MDR WAS SUBMITTED WITHIN A 30-DAY WINDOW.

    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 DAMAGED CATHETER IS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ONE 4FR SL POWERPICC CATHETER WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED USE RESIDUE ON THE CATHETER. A MICROSCOPIC OBSERVATION REVEALED A CIRCUMFERENTIAL SEPARATION IN THE CATHETER TUBING AT THE 16 CM DEPTH MARKING. THE OTHER SECTION OF CATHETER WAS NOT RETURNED WITH THE SAMPLE. THE FRACTURE SURFACES OF THE SPILT WERE OBSERVED TO BE ROUGH AND UNEVEN WITH MINOR ROUNDED EDGES. WHILE THE EXACT CAUSE OF THE SEPARATION IN THE RETURNED CATHETER COULD NOT BE DETERMINED, POSSIBLE CONTRIBUTING FACTORS INCLUDE MATERIAL FATIGUE, COMPRESSION DAMAGE, AND/OR EXCESSIVE TENSILE (PULLING) FORCES. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER POWERPICC INSERTED IN THE RIGHT BASILIC VEIN, TOTAL RUPTURE INTERNALLY REQUIRING CATHETER REMOVAL THROUGH IVR.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED: 11-JUL-2025. REMOVAL CARRIED OUT WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897937 POWERPICC, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REHU2499 00801741138966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention