BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 1201906 · Received October 16, 2008

    Report

    Report Number
    MW5008603
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ARROW
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON WAS TO HAVE A ROUTINE PROCEDURE DONE, INVOLVING THE INSERTION OF A PICC LINE FOR DELIVERY OF ANTIBIOTIC TREATMENT FOR CYSTIC FIBROSIS. A 1 FOOT LONG PIECE OF GUIDEWIRE BROKE OFF DURING INSERTION OF AN ARROW-BRAND PERIPHERALLY INSERTED CENTRAL CATHETER - PICC LINE. SUBSEQUENTLY, MY SON HAD TO BE EMERGENCY-TRANSFERRED TO ANOTHER HOSPITAL TO HAVE THE FOREIGN OBJECT REMOVED FROM HIS CARDIOVASCULAR SYSTEM. REMOVAL WAS SUCCESSFUL AND THE PT IS DOING WELL SO FAR. NEVERTHELESS, THIS SHOULD NOT HAPPEN. AFTER SOME RESEARCH ON THE SUBJECT I WAS ABLE TO FIND AN ADVISORY BY THE AUSTRALIAN GOVERNMENT, IMPLICATING THE SAME MFR FOR PROBLEMS OF THE SAME NATURE IN MULTIPLE CASES IN OTHER COUNTRY. - ADVISORY WAS ISSUED ON OCTOBER 10TH 2008. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: DELIVERY OF ANTIBIOTICS FOR TREATMENT OF LUNG-INFECTION OF OLD PT WITH CYSTIC FIBROSIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW PICC LINE-PERIPHERALLY INSERTED CENTRAL CATHETER LJS ARROW

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| S