BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSTRAP ENDOTRACHEAL TUBE HOLDER

    MDR report key: 1163628 · Received September 9, 2008

    Report

    Report Number
    9616567-2008-00074
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 12, 2008
    Manufacturer
    SMITH MEDICAL, ASD.
    Product Code
    CBH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT PRODUCT WAS AVAILABLE FOR RETURN; HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. SMITHS WAS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE WITHOUT RETURNED PRODUCT EVALUATION. THE DEVICE HISTORY COULD NOT BE REVIEWED WITHOUT A REPORTED LOT NUMBER AS A REFERENCE. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD SAMPLES BECOME AVAILABLE FOR ANALYSIS. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PATIENT HAD BEEN BITING HIS ENDOTRACHEAL TUBE AND A TRACHEOTOMY WAS PERFORMED. A BROKEN PIECE FROM A SECUREEASY WAS FOUND IN THE BRONCHUS OF A PATIENT DURING A FIBEROPTIC ENDOSCOPY FOLLOWING THE TRACHEOTOMY. THE PIECE WAS EXTRACTED AND THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSTRAP ENDOTRACHEAL TUBE HOLDER ENDOTRACHEAL TUBE HOLDER CBH SMITH MEDICAL, ASD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK