BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-CATH ML (3.0FR) (SINGLE LUMEN)

    MDR report key: 319607 · Received March 11, 2001

    Report

    Report Number
    2925153-2001-00002
    Event Type
    Injury
    Date Received
    March 11, 2001
    Date of Event
    February 7, 2001
    Report Date
    February 15, 2001
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER IN PLACE ONLY 1 DAY. V-CATH ML IV CATHETER NOT INFUSING. NURSE UNABLE TO CLEAR LINE, CALLED MD. ORDERS TO DISCONTINUE IV CATHETER. NO REAL RESISTANCE NOTED, BUT CATHETER SNAPPED IN 2. MD CALLED. PT TO ER FOR ULTRASOUND, FOUND CATHETER TIP SURROUNDED IN A CLOT IN PT'S LEFT ARM. HAD OUTPATIENT SURGERY TO REMOVE CATHETER (10 CM LEFT IN ARM-REMOVED. IV INSTERTED ONE DAY EARLIER WITHOUT DIFFICULTY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10930 V-CATH ML (3.0FR) (SINGLE LUMEN) PERIPHERALLY INSERTED RADIOPAQUE SILICONE CATHETER DQO HDC CORP. 3FR. MIDLINE V-CATH 1168

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O| R SURGERY TO REMOVE DEVICE 2001. FOLLOW UP PHONE| CALL 2/2001. PT REPORTEDLY DOING FINE NOW.