BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE 6FR D/L MI W/SCUFF

    MDR report key: 7923634 · Received October 1, 2018

    Report

    Report Number
    3006260740-2018-02681
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Report Date
    October 1, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036606
    PMA / PMN Number
    K051417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN FLUSHING A DOUBLE LUMEN CHRONIC CATHETER, ONE LUMEN ALLEGEDLY DID NOT FLUSH. IT WAS FURTHER REPORTED THAT THE PATIENT'S FAMILY MEMBER INSTALLED A DOSE OF ANTICOAGULATION MEDICATION THAT CLEARED THE LUMEN AFTER SOME TIME. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763671 POWERLINE 6FR D/L MI W/SCUFF CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 0700615 RECS0045 00801741036606

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR