BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE 5 FR S/L MI W/SCUFF

    MDR report key: 8529505 · Received April 18, 2019

    Report

    Report Number
    3006260740-2019-01001
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBERS FOR THE THREE (3) MALFUNCTIONS WERE PROVIDED AND THE LOT HISTORY REVIEWS WERE PERFORMED. THE SAMPLES WERE RETURNED FOR THE THREE MALFUNCTIONS; THE THREE INVESTIGATIONS ALL CONFIRMED FOR FLUID LEAK. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. H10: G4 H11: H6(RESULTS, CONCLUSION) 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.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0700515 CHRONIC CATHETER ALLEGEDLY IDENTIFIED A LEAK. THESE REPORTS WERE RECEIVED FROM ONE SOURCE. OF THE THREE EVENTS, ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE ONE PATIENT WAS 7 YEARS OF AGE AND MALE. THE WEIGHT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    FOR THE THREE REPORTED EVENTS, THREE DEVICES WERE RETURNED TO BD AND EVALUATED. THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0700515 CHRONIC CATHETER ALLEGEDLY IDENTIFIED A LEAK. THESE REPORTS WERE RECEIVED FROM ONE SOURCE. OF THE THREE EVENTS, ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE ONE PATIENT WAS (B)(6) YEARS OF AGE AND MALE. THE WEIGHT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321889 POWERLINE 5 FR S/L MI W/SCUFF CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 0700515 RECV0229, RECW2074 00801741036583

    Patients

    Seq Age Sex Outcome Treatment
    1