BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CATH MIDLINE CATHETER

    MDR report key: 74610 · Received March 7, 1997

    Report

    Report Number
    MW1010905
    Event Type
    Malfunction
    Date Received
    March 7, 1997
    Date of Event
    February 14, 1997
    Report Date
    February 26, 1997
    Manufacturer
    HDC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER PLACED 2/9/97 IN LEFT CEPHALIC VEIN. PT DISCHARGED HOME. HOME INFUSION CO WAS NOTIFIED ON 2/14 THAT THE CATHETER WAS LEAKING AT THE HUB/CATHETER JUNCTION. THE LINE WAS REPLACED WITH A NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH MIDLINE CATHETER Implant MIDLINE INFUSION CATHETER 4FR 8 IN DQO HDC * 1030

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other