BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 394426 · Received January 30, 2002

    Report

    Report Number
    2925153-2001-00018
    Event Type
    Other
    Date Received
    January 30, 2002
    Date of Event
    December 17, 2001
    Report Date
    December 20, 2001
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PICC LINE PLACED IN 2001 FAILED 4 DAYS LATER WHEN THE EXTERNAL CATHETER BEGAN LEAKING SPONTANEOUSLY AND HAD TO BE REPAIRED. HOWEVER, BLOOD HAD CLOTTED IN THE LUMEN AND TPA WAS ADMINISTERED WITHOUT SUCCESS. WHEN THE LINE WAS REMOVED, IT FRACTURED INSIDE THE PT LEAVING ABOUT 26CM INTERNALLY. THE EMBOLUS AND CATHETER WAS REMOVED IN THE CATH LAB AND THE PT SPENT 2 NIGHTS IN THE ICU FOR CARDIAC MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * DQO HDC CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1