BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERI-I-BRONCH ET TUBE, 37 FR, LS

    MDR report key: 2093501 · Received April 6, 2011

    Report

    Report Number
    3003898360-2011-00126
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 14, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DOCTOR DISCOVERED THAT THE CONTENT OF THE PRODUCT WAS DIFFERENT THAN THE OUTER PACKAGING LABEL. THE OUTER BOX LABEL INDICATED THAT PRODUCT WAS (B)(4), HOWEVER, PRODUCT (B)(4) WAS IN THE BOX WHICH IS AN ET TUBE, SHER-I-BRONCH, RS, 37 FR. THIS DEFECT WAS DISCOVERED PRIOR TO USE ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SHERI-I-BRONCH ET TUBE, 37 FR, LS ET TUBE BTR TELEFLEX MEDICAL NA 01F1000353

    Patients

    Seq Age Sex Outcome Treatment
    1