BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 66085 · Received December 31, 1996

    Report

    Report Number
    66085
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    August 21, 1996
    Report Date
    August 26, 1996
    Manufacturer
    BARD INTERVENTIONAL PRODUCTS C.R. BARD, INC.
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, 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 A LOW MANIPULATION AND WITHDRAWAL WITHOUT RISK OF CAUSING BLEEDING BY STICKING PT WITH NEEDLE. DEVICE WAS DISPOSED OF, THEREFORE, UNAVAILABLE TO EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD SCLEROTHRAPY NEEDLE OPTIC YELLOW FLEXITIP FBK BARD INTERVENTIONAL PRODUCTS C.R. BARD, INC. * 88FG0191 CATH LGTH 230CM

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention OLYMPUS, LIGHTSOURCE, OLYMPUS.| GIF100 VIDEO SCOPE, OLYMPUS, COMPUTER TOWER, ,