BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIENS ECG TIP LOCATION TECHNOLOGY FOR PICC PLACEMENT

    MDR report key: 3010695 · Received March 12, 2013

    Report

    Report Number
    MW5029366
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER NORMAL PROTOCOLS, A PICC LINE CATHETER WAS INSERTED WITHOUT RADIOGRAPHIC CONFIRMATION OF PROPER LOCATION OF THE CATHETER. THE PICC LINE WAS INSERTED TO DELIVER ANTIBIOTICS. IT IS BELIEVED THAT THE PICC LINE MAY HAVE BEEN INSERTED TOO DEEPLY WHICH MAY HAVE CONTRIBUTED TO A VENTRICULAR TACHYCARDIA. THE ISSUE RESOLVED AFTER THE PICC LINE WAS ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104558 SAPIENS ECG TIP LOCATION TECHNOLOGY FOR PICC PLACEMENT SAPIENS ECG TIP LOCATION TECHNOLOGY FOR PICC PLACEMENT LJS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR