BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY

    MDR report key: 3271757 · Received July 23, 2013

    Report

    Report Number
    2523676-2013-00208
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REF# 4251687-02, LOT# 2K07258232, NEEDLESTICK INJURY. PRODUCT INSERTED INTO PT, REMOVED NEEDLE AND PLACED BACK INTO THE BLISTER LID, THEN FINISHED INSERTION PROCEDURE. HE THEN GRASPED BLISTER LID TO DISPOSE AND FELT THE NEEDLE STICK HIM. CLINICIAN STATED THAT HE DOES NOT KNOW IF CLIP WAS FULLY DEPLOYED OR WAS DISLODGED BY HIS GRASP. HE WAS ABLE TO CREATE DISLODGEMENT OF THE CLIP OF A CLEAN SAMPLE BY USING THE SAME GRASP. NO SAMPLE. PLEASE REFER MFR REF # 9610825-2013-00208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342059 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 2K07258232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other