BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHANE UMB CATH

    MDR report key: 5922806 · Received September 1, 2016

    Report

    Report Number
    3009211636-2016-00368
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 25, 2016
    Report Date
    August 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINALLY REPORTED AS THE CUSTOMER REPORTS THE DUAL LUMEN UMBILICAL VESSEL CATHETER MALFUNCTIONED WHILE ATTACHED TO A PATIENT IN THE ICN AND SHOULD BE THE CUSTOMER REPORTS THE UMBILICAL VESSEL CATHETER MALFUNCTIONED WHILE ATTACHED TO A PATIENT IN THE ICN. BRAND NAME WAS ORIGINALLY REPORTED AS 3.5FR DUAL-LUMEN UVC CATH AND SHOULD BE 3.5FR URETHANE UMB CATH. MODEL# ORIGINALLY REPORTED AS 8888160531 AND SHOULD BE 8888160333, CATALOG# ORIGINALLY REPORTED AS 8888160531 AND SHOULD BE 8888160333, LOT# ORIGINALLY REPORTED AS 1609500029 AND SHOULD HAVE BEEN LEFT BLANK AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 09/01/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE UMBILICAL VESSEL CATHETER MALFUNCTIONED WHILE ATTACHED TO A PATIENT IN THE ICN. THE CUSTOMER FURTHER REPORTS THAT THE CATHETER LEAKED AROUND THE 10CM-12CM OF THE CATHETER WHEN SOLUTION WAS CONNECTED. THE CUSTOMER FURTHER REPORTS THAT CHLORAPREP WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO HANDLE THE CATHETER DURING INSERTION. IT WAS NOT DIFFICULT TO SECURE AND WAS SECURED BY SUTURE. THE UVC WAS INSERTED (B)(6) IN THE UMBILICAL SITE. THE UVC WAS IN CONTINUOUS USE. A 5ML SYRINGE 1/2 INCH NEEDLE, WAS USED TO FLUSH THE LINE WITH NS CHEP. THE UVC WAS REMOVED (B)(6) AND WAS NOT REPLACED. THE STATUS OF THE PATIENT IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 08/29/2016 THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THE DUAL LUMEN UMBILICAL VESSEL CATHETER MALFUNCTIONED WHILE ATTACHED TO A PATIENT IN THE ICN. THE ITEM LEAKED WHEN ORDERED SOLUTION WAS CONNECTED TO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574964 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 1609500029

    Patients

    Seq Age Sex Outcome Treatment
    1