BEUDAMED
    FDA Adverse Event Other Summary report: N

    3.5/5.0FR PU UVC TRAY

    MDR report key: 3713679 · Received March 17, 2014

    Report

    Report Number
    1317749-2014-00156
    Event Type
    Other
    Date Received
    March 17, 2014
    Report Date
    February 26, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
    Product Code
    FOS
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. A 3CC SYRINGE FOR FLUSH WAS USED AND THEN THEY REALIZED THAT A 5CC SYRINGE FOR FLUSH IS RECOMMENDED. PROVIDINE WAS USED TO CLEAN THE DEVICE FOR INSERTION, NO ALCOHOL OR ACETONE WAS USED. AFTER INSERTION, NURSES USE CHLOROHEXIDINE FOR HUB CLEANING. THEY DO NOT ROUTINELY CLEAN THE CATHETER OR TUBING. THE TUBING IS CHANGED DAILY WITH EACH NEW TPN. THE CUSTOMER REPORTS THAT THEY DO NOT KNOW WHEN THE UVC WAS REMOVED. THE DEVICE WAS NOT REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER STATES THAT THEY HAD AN ISSUE WITH A BABY AT (B)(6) WEEKS OLD AND IN THIS INCIDENT SEPSIS AP ON DAY 8 OF LIFE WHICH REQUIRED ANTIBIOTICS. THE PATIENT WAS ADMINISTERED VANCOMYCIN AND CONTINUED TO HAVE POSITIVE CULTURES FOR SEVERAL DAYS. A SECOND ANTIBIOTIC WAS NECESSARY. THE CUSTOMER FURTHER REPORTS THAT THEY HAVE NOT CHANGED ANY PROCESSES FOR INSERTION. AFTER THE FIRST SEPSIS INCIDENT THEY IMPLEMENTED CHG 3% AFTER DAY 2. THE CUSTOMER STATES THAT THE SAME NURSES AND PRACTITIONERS INSERT THE LINE. THE CUSTOMER FURTHER REPORTS THAT PVP WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO SECURE. THE CATHETER WAS SECURED WITH A STITCH. THE SPECIFIC DATE OF INSERTION IS NOT KNOWN, ONLY AN APPROXIMATE. THE UVC WAS INSERTED IN THE UMBILICUS AND WAS IN CONTINUOUS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156808 3.5/5.0FR PU UVC TRAY UMBILICAL VESSEL CATHETER FOS COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 8888160119 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA