BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 3043330 · Received March 8, 2013

    Report

    Report Number
    1317749-2013-00086
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 8, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PRODUCT MONITORING MADE ATTEMPTS TO OBTAIN ADD'L INFO ON 02/12/2013, 02/28/2013, 03/04/2013, AND 03/05/2013. TO DATE NO RESPONSE HAS BEEN RECEIVED. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

    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 REPORTS THAT WHEN MAKING IT ZERO, (WHEN THE DEVICE WAS UNDER INVASIVE PRESSURE) THE NURSE REALIZED THAT HER SYRINGE DREW IN AIR. SHE THEN NOTICED THAT THE DEVICE WAS PIERCED AT THE END OF THE RIGID CONNECTION. THE DEVICE WAS THEN REMOVED WITH NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100697 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 217003X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK