BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 117292 · Received June 25, 1997

    Report

    Report Number
    117292
    Event Type
    Injury
    Date Received
    June 25, 1997
    Date of Event
    January 19, 1997
    Report Date
    January 21, 1997
    Manufacturer
    C. R. BARD
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCLEROTHERAPY NEEDLE FAILED TO RETRACT AFTER INJECTION. PT WAS NOT INJURED. NEEDLE SHOULD RETRACT TO ALLOW MANIPULATION AND WITHDRAWAL WITHOUT RISK OF CAUSING BLEEDING BY STICKING PT WITH NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD OPTIC YELLOW FLEXITIP SCLEROTHERAPY NEEDLE FBK C. R. BARD * 88HG0033, CATH LGTH 230CM

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 3. OLYMPUS VIDEO SYSTEM| 2. SPACELABS CARDIAC MONITOR| 1. OLYMPUS ENDOSCOPE.