BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC, 3CG

    MDR report key: 22320006 · Received June 24, 2025

    Report

    Report Number
    3006260740-2025-04220
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    June 3, 2025
    Report Date
    August 19, 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
    FR
    Reporter Occupation
    PHYSICIAN
    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. 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

    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 CATHETER BREAK WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4FR SL POWERPICC CATHETER. THE DAMAGE OBSERVED IN THE RETURNED SAMPLE WAS CHARACTERISTIC OF OVER-PRESSURIZATION (BURST) DAMAGE. THIS CAN OCCUR THROUGH THE USE OF SYRINGES SMALLER THAN 10ML, BY FLUSHING AGAINST AN OCCLUSION, OR DUE TO EXCESSIVE FORCE APPLIED DURING INFUSION PROCEDURES. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A COMPLETE FRACTURE WAS OBSERVED NEAR THE 7 CM DEPTH MARKER. THIS CATHETER DAMAGE WAS TYPICAL OF A BURST, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: ¿ TENSILE WEAKNESS AT THE FRACTURE SITE (DUE TO MATERIAL BALLOONING PRIOR TO BURST) ¿ THE CATHETER MATERIAL WAS VISIBLY LIGHTER IN COLOR AT THE FRACTURE SITE A MEASUREMENT OF THE CATHETER TUBING WALL THICKNESS WAS TAKEN AND FOUND TO BE WITHIN SPECIFICATION. AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER, DURING THE PATIENT'S TRANSFUSION, A LEAK WAS OBSERVED AT THE PUNCTURE SITE. TRANSFUSION STOPPED, PICC LINE REMOVED. ON REMOVAL OF THE PICC LINE, RUPTURE AT THE 7TH CM. EMERGENCY INTERVENTION BY THE VASCULAR SURGEON TO RECOVER THE DISTAL END, WHICH HAD MIGRATED INTO THE LEFT VENTRICLE, RESULTING IN INTERRUPTION OF TRANSFUSION, REMOVAL OF LINE, AND EMERGENCY SURGERY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: NOTE RECEIVED WITH RETURNED SAMPLE INDICATED DATE OF (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390761 POWERPICC, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJY2718 00801741138966

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention