BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 3170474 · Received May 24, 2013

    Report

    Report Number
    1317749-2013-00165
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER STATES THE UVC WAS FUNCTIONING CORRECTLY AFTER FOLLOWING PROTOCOL, IN REGARDS TO CLEANING AND INSERTING. THE CUSTOMER FURTHER REPORTS A LEAK WAS THEN DISCOVERED. THE CUSTOMER STATES THAT THE LEAK IN THE CONNECTION WAS LOCATED BETWEEN THE CONNECTOR AND THE CATHETER. THE LEAK OCCURRED JUST BELOW THE MOLDED STRAIN RELIEF. THE CUSTOMER STATED THAT THEY USED CHLORIDE HEXIDINE TO CLEAN THE AREA AND THE AREA WAS COMPLETELY DRY PRIOR TO INSERTION. THE CUSTOMER DID NOT FIND IT DIFFICULT TO HANDLE THE CATHETER DURING INSERTION AND IT WAS NOT DIFFICULT TO SECURE. THE CUSTOMER USED A SUTURE TO SECURE THE CATHETER. THE CUSTOMER ADVISED THE CATHETER WAS INSERTED ON (B)(6) 2013 AND IT WAS INSERTED IN THE UMBILICAL ARTERY. THIS WAS A CONTINUOUS FEED WITH 0.5 ML SALINE PER HOUR. THE CUSTOMER ADVISED THAT THE CATHETER WAS REMOVED ON (B)(6) 2013. THE UVC WAS NOT REPLACED AND THE STATUS OF THE PATIENT IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230901 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK