BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CATH

    MDR report key: 13883 · Received June 9, 1994

    Report

    Report Number
    MW1002408
    Event Type
    Malfunction
    Date Received
    June 9, 1994
    Date of Event
    May 31, 1994
    Report Date
    June 8, 1994
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE RPTR STATED THAT THE INTRODUCER NEEDLE SHEATH SPLIT WHEN NEEDLE WAS REMOVED AFTER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH INTRODUCER NEEDLE DQO HDC CORP. 380-25 1007

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR