BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SLICK SET UNCUFFED 2.5MM

    MDR report key: 4173478 · Received September 15, 2014

    Report

    Report Number
    8040412-2014-00201
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 20, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO THE USER FACILITY TO DETERMINE IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION. TO DATE, NO RESPONSE FROM THE USER FACILITY. A DHR (DEVICE HISTORY RECORD) REVIEW WAS CONDUCTED ON REPORTED LOT# 11KE45. REVIEW ON DATES FROM PRIMARY PROCESSES SHOWED THAT THERE WAS NO PRODUCTION THROUGH THE SAME DAY FOR TUBE SIZE 2.5MM AND SIZE 3.5MM. BASED ON THE DHR CONDUCTED, THERE WERE NO ISSUES THAT COULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. DHR REVIEW FOR BOTH SIZES OF 2.5 MM AND 3.5MM SLICK SET (ENDOTRACHEAL TUBE) WAS CONDUCTED AND NO ISSUE WAS FOUND. NO PHYSICAL ASSESSMENT COULD BE CONDUCTED SINCE THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION. ACCORDING TO THE INVESTIGATION CONDUCTED, THE COMPLAINT OF WRONG PRODUCT PACKAGED COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE PACKAGE WAS LABELED AS A 2.5MM ENDOTRACHEAL TUBE; HOWEVER, IT WAS PACKAGED WITH A SIZE 3.5MM ENDOTRACHEAL TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569328 RUSCH SLICK SET UNCUFFED 2.5MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 11KE45

    Patients

    Seq Age Sex Outcome Treatment
    1