BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-T-INTIMA

    MDR report key: 2920185 · Received November 26, 2012

    Report

    Report Number
    2920185
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BD MEDICAL
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENTIRE SILICONE TIP OF A SAF-T-INTIMA (INTRAVENOUS CATHETER) DISCONNECTED INTO PT'S VEIN. SURGICAL PROCEDURE PERFORMED TO REMOVE SAF-T-INTIMA TIP. PT TOLERATED WELL, NO PERMANENT HARM TO PT. PRODUCT PACKAGE DISCARDED AFTER INSERTION OF SAF-T-INTIMA PRIOR TO INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-INTIMA IV ANGIOSET FOZ BD MEDICAL 383346 ZO60145 (PRESUMED)

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R