BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH CRYSTAL TRACHEOSTOMY TUBE, CUFFED 9.0MM

    MDR report key: 1843386 · Received September 21, 2010

    Report

    Report Number
    8040412-2010-00063
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 24, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JOH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT AVAILABLE FOR EVALUATION BY MANUFACTURER AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE PACKAGING FOR THE CRYSTAL TRACH TUBE CUFFED 9.0 MM IS LABELED AS A SIZE 9, BUT THE ACTUAL TUBE INSIDE THE PACKAGE IS A SIZE 8. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH CRYSTAL TRACHEOSTOMY TUBE, CUFFED 9.0MM TRACHEOSTOMY TUBE JOH TELEFLEX MEDICAL NA 09JE38

    Patients

    Seq Age Sex Outcome Treatment
    1