BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-CATH

    MDR report key: 251163 · Received November 23, 1999

    Report

    Report Number
    MW1017627
    Event Type
    Injury
    Date Received
    November 23, 1999
    Date of Event
    November 8, 1999
    Report Date
    November 12, 1999
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    NURSE PERFORMING A CATHETER EXCHANGE PROCEDURE WITH A 4 FR INTRODUCER/PICC LINE REPLACING A 3 FR PICC LINE. INTRODUCER FRACTURED AT INSERTION SITE, LEAVING APPROX 44 CM OF CATHETER IN THE ANTECUBITAL. PT TAKEN TO ER AND SENT HOME WITH TOURNIQUET UNTIL NEXT DAY. BY NEXT DAY THE CATHETER HAD MIGRATED AND HAD TO BE REMOVED THROUGH THE GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH INTRODUCER FOR PICC LINE DQO HDC CORP. SAFE-T-PEEL INTRODUCER *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L