BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE CV CATHETER, POLYURETHANE DUAL-LUMEN, 6F

    MDR report key: 14876266 · Received June 30, 2022

    Report

    Report Number
    3006260740-2022-02485
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 9, 2022
    Report Date
    September 28, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741036606
    PMA / PMN Number
    K051417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Additional Manufacturer Narrative · 0

    H10: UPON FURTHER REVIEW, IT WAS IDENTIFIED THAT THE PRODUCT CATALOG NUMBER BELONGS TO PERIPHERAL INTERVENTION (PI) - TEMPE BUSINESS UNIT. THEREFORE, BUSINESS UNIT FOR THE COMPLAINT HAS BEEN CHANGED FROM VASCULAR ACCESS DEVICES (VAD) - SALT LAKE CITY TO PERIPHERAL INTERVENTION (PI) - TEMPE. H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: ONE 6 FR DL POWERLINE CATHETER WAS RETURNED FOR EVALUATION. GROSS, MICROSCOPIC VISUAL, TACTILE EVALUATION AND FUNCTIONAL TESTING WERE PERFORMED. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED CATHETER SPLIT AND FLUID LEAK ISSUES AS A PARTIAL CIRCUMFERENTIAL SPLIT WAS NOTED AT THE INTERFACE BETWEEN THE EXTENSION TUBING AND LUER HUB. DURING FUNCTIONAL TESTING, THE CATHETER WAS INFUSED WITH WATER AND A LEAK WAS FOUND TO EMANATE AT THE PROXIMAL END OF THE EXTENSION TUBING ATTACHED TO THE PURPLE HUB. FURTHERMORE, DURING THE SAMPLE EVALUATION COMPLETE DIAGONAL BREAK WAS NOTED ON THE DISTAL END OF THE CATHETER WAS CONSIDERED TO BE AN INCIDENTAL FINDINGS SINCE IT WAS NOT RELATED TO THE ORIGINAL REPORTED EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: B5, D4 (EXPIRY DATE: 11/2025), G3, H6 (DEVICE). H11: D1, D2, D4, G1, G2, H6 (METHOD, RESULT). 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER "THE FLUSH PORTS WERE LEAKING/CRACKING AT THE CONNECTIONS." NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE PORT ALLEGEDLY CRACKED AT THE CONNECTION. IT WAS FURTHER REPORTED THAT THE PORT WAS ALLEGEDLY LEAKED. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015523 POWERLINE CV CATHETER, POLYURETHANE DUAL-LUMEN, 6F CHRONIC CATHETERS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REFX1213 00801741036606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other