BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINE 5FR S/L MI W/SCUFF

    MDR report key: 8191838 · Received December 21, 2018

    Report

    Report Number
    3006260740-2018-03742
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    September 23, 2018
    Report Date
    May 2, 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 CONDUCTED FOR THE INVESTIGATION AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: ONE 5 FR S/L POWERLINE POLYURETHANE CATHETER WITH SURECUFF WAS RETURNED FOR EVALUATION. A VISUAL, TACTILE AND FUNCTIONAL EVALUATION WAS PERFORMED. A PARTIAL CIRCUMFERENTIAL C-SHAPED CRACK WAS NOTED, 5MM DISTAL TO THE SUTURE WING. THE TACTILE EVALUATION WAS UNREMARKABLE, EXCLUDING INCREASED ELASTICITY AT THE CRACK SITE. THE SAMPLE WAS PATENT TO INFUSION, HOWEVER, LEAKING WAS OBSERVED AT THE CRACK SITE. THEREFORE, THE INVESTIGATION CAN BE CONFIRMED AS REPORTED FOR 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: A REVIEW OF THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROCEDURAL INSTRUCTIONS, 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
    1030611 POWERLINE 5FR 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