BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATLOCK R

    MDR report key: 2437780 · Received January 27, 2012

    Report

    Report Number
    MW5024052
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Date of Event
    December 24, 2011
    Report Date
    January 27, 2012
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S 20 GAUGE IV CATHETER TUBING "STAT LOCK R" BRAND FAILED DURING IV CONTRAST BOLUS. CATHETER TUBING SPLIT OPEN, SPRAYING PT'S RIGHT SIDE FACE AND ARM WITH CONTRAST SOLUTION ISOVUE. REMOVED WITH WARM WASHCLOTH. NO APPARENT INJURY, PAIN OR DISCOMFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATLOCK R INTRAVENOUS TUBING FPA BARD MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR