BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUSCH STYLET

    MDR report key: 2132623 · Received June 13, 2011

    Report

    Report Number
    MW5020976
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 13, 2011
    Manufacturer
    TELEFLEX
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREMATURE INFANT REQUIRED INTUBATION FOLLOWING DELIVERY. STYLET NOTED TO BE "STICKING" DURING ATTEMPTS TO REMOVE IT FROM THE ENDOTRACHEAL TUBE; TUBE/STYLET REMOVED AND PT WAS REINTUBATED. THE STYLET WAS DISCARDED. I AM PROVIDING THE STYLET LOT NUMBERS -2- THAT WERE AVAILABLE FOR USE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH STYLET STYLET BSR TELEFLEX 10LG22, 11AG02

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Disability STYLET USED WITH SMITHS ENDOTRACHEAL TUBE,| SIZE 2.5 -ITEM # 100-141-025-