BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINE 5 FR S/L MI W/SCUFF

    MDR report key: 8191833 · Received December 21, 2018

    Report

    Report Number
    3006260740-2018-03741
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    September 17, 2018
    Report Date
    March 22, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036583
    PMA / PMN Number
    K050185
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A COMPLETE MANUFACTURING REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: ONE 5FR SINGLE LUMEN POWERLINE CATHETER FOR EVALUATION. VISUAL INSPECTION IDENTIFIED A SMALL HOLE 4MM DISTAL TO THE SUTURE WING. FUNCTIONAL TESTING NOTED THAT THE DEVICE WAS PATENT TO INFUSION AND ASPIRATION WITH A LEAK NOTED FROM THE IDENTIFIED HOLE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE ALLEGED EXTERNAL CATHETER LEAK. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: THE REVIEW OF THE IFU (INSTRUCTIONS FOR USE), INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS HAS NOT BEEN PERFORMED. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALLEGED LEAK WAS IDENTIFIED WHICH LEAD TO A SMALL HOLE/BREAK ON THE CATHETER PROXIMAL TO THE SUTURE WINGS AS AN ATTEMPT WAS MADE TO ADMINISTER TPN. IT WAS FURTHER REPORTED THAT THE PATIENT IS A HIGH RISK FOR LINE SEPSIS AND HAD COMPLETED LINE SEPSIS TREATMENT TWO DAYS PRIOR TO THE DISCOVERED LEAK. REPORTEDLY, THE CATHETER HAD TO BE REPLACED DUE TO THE PATIENT BEING TPN DEPENDENT, REQUIRING HOSPITALIZATION AND ANESTHESIA FOR LINE REPLACEMENT. CURRENT PATIENT STATUS WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALLEGED LEAK WAS IDENTIFIED WHICH LEAD TO A SMALL HOLE/BREAK ON THE CATHETER PROXIMAL TO THE SUTURE WINGS AS AN ATTEMPT WAS MADE TO ADMINISTER TPN. IT WAS FURTHER REPORTED THAT THE PATIENT IS A HIGH RISK FOR LINE SEPSIS AND HAD COMPLETED LINE SEPSIS TREATMENT TWO DAYS PRIOR TO THE DISCOVERED LEAK. REPORTEDLY, THE CATHETER HAD TO BE REPLACED DUE TO THE PATIENT BEING TPN DEPENDENT, REQUIRING HOSPITALIZATION AND ANESTHESIA FOR LINE REPLACEMENT. CURRENT PATIENT STATUS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030607 POWERLINE 5 FR S/L MI W/SCUFF CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS 0700515 UNKNOWN 00801741036583

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization