BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5FR DUAL-LUMEN UVC CATH

    MDR report key: 2255432 · Received September 12, 2011

    Report

    Report Number
    1317749-2011-00248
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Report Date
    August 11, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY UPON COMPLETION, THE RESULTS WILL BE FORWARDED. QA HAS SOUGHT ADDITIONAL INFO VIA PHONE ON 08/12/2011, 08/17/2011 AND 08/19/2011, ON 08/19/2011 RPTR WAS NOT ABLE TO PROVIDED ADDITIONAL INFO ON THE INCIDENT BUT WOULD FORWARD MY REQUEST ALONG TO THE FLOOR NURSE. ADDITIONAL REQUESTS WERE SENT BY E-MAIL ON 08/24/2011, 08/30/2011 AND ON 09/08/2011. IF ADDITIONAL INFO IS OBTAINED THE MEDWATCH FORM WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTED THAT THE UVC WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5FR DUAL-LUMEN UVC CATH UVC FOS COVIDIEN 8888160556 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK