BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERAL INTRAVASCULAR CENTRAL CATHETER

    MDR report key: 3954809 · Received July 17, 2014

    Report

    Report Number
    3006260740-2014-00364
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC WAS FOUND TO BE INFECTED AND WAS REMOVED BY A WARD NURSE WITHOUT ANY RESISTANCE. ON REMOVAL IT WAS FOUND THAT APPROX 3CM OF THE TIP WAS MISSING, THE PATIENT WAS SENT TO RADIOLOGY AND THE 3CM TIP WAS VISIBLE IN THE SUBCLAVIAN VEIN. THE NURSE HAS INFORMED US THAT THE PATIENT WAS RELUCTANT TO LET HCP PROFESSIONALS TOUCH THE PICC AND WAS CARING FOR THE PICC HERSELF, DESPITE IT BEING PLACED IN THE UPPER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419296 PERIPHERAL INTRAVASCULAR CENTRAL CATHETER CATHETER INTRAVASCULAR GREATER LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention