BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5. OFR URETHANE UMB CATH

    MDR report key: 3784573 · Received March 24, 2014

    Report

    Report Number
    1317749-2014-00164
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THEY SAW THERE WAS SOME BLOOD LOSS. THEY ARE NOT SURE IF THE UVC WAS DEFECTIVE OR IF THE NURSE KINKED THE LINE. THE CUSTOMER FURTHER REPORTED THAT THE UVC LEAKED JUST ABOVE THE HUB WHERE THE EXTENSION TUBING MEETS THE HUB. CHG WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. THE UVC WAS NOT DIFFICULT TO HANDLE DURING INSERTION AND WAS NOT DIFFICULT TO SECURE. THE UVC WAS SECURED WITH SUTURES. THE UVC WAS IN CONTINUOUS USE. NORMAL SALINE WAS USED TO FLUSH THE LINE. THE DEVICE WAS NOT REPLACED. THE CUSTOMER REPORTS THAT THE STATUS OF THE PATIENT IS STABLE. THE DATE OF INSERTION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173429 5. OFR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160341 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO