BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12518528 · Received September 23, 2021

    Report

    Report Number
    8040412-2021-00231
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 1, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBI
    UDI-DI
    14026704617408
    PMA / PMN Number
    K141888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). THE CUSTOMER RETURNED ONE UNIT 5-16037 ET TUBE, SHER-I-BRONCH, LS, 37 FR FOR INVESTIGATION. THE RETURNED ET TUBE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED ET TUBE CONFIRMED THAT MULTIPLE PIECES OF THE SCOPE'S COATING WAS IN THE TRACHEAL SIDE OF THE TUBE. THE SCOPE THAT WAS DAMAGED WAS NOT RETURNED. THE SAMPLE WAS SENT TO THE MANUFACTURING SITE FOR FURTHER INSPECTION OF THE TUBE. THERE WERE NO ABNORMALITIES (INCLUDING NO SHARP EDGES) OBSERVED WITH THE TUBE THAT WOULD SUGGEST THE TUBE CAUSED THE COATING OF THE SCOPE TO SHEAR OFF. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. IT IS POSSIBLE THAT THE COATING ON THE SCOPE WAS DAMAGED PRIOR TO INSERTION INTO THE TUBE, BUT THIS COULD NOT BE CONFIRMED. THEREFORE, THE ROOT CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. THIS APPEARS TO BE AN ISOLATED INCIDENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON THIS ISSUE. CORRECTED DATA: SECTION D.3.-MANUFACTURER ADDRESSS CORRECTED TO TELEFLEX MEDICAL, MORRISVILLE, NC.

    Description of Event or Problem · 0

    IT WAS REPORTED "WE CURRENTLY USE YOUR SHERIDAN DUEL LUMEN ETT TUBES FOR OUR THORACIC CASES. TODAY WE HAD AN UNFORTUNATE ISSUE ARISE WITH ONE OF YOUR TUBES. DR. NECHALA, WHO USES THESE TUBES WEEKLY, INSERTED THE FLEXIBLE INTUBATING SCOPE INTO THE TUBE, AND AS IT WENT DOWN THE TUBE, A PIECE OF THE SCOPES COATING WAS CUT OFF. DR. NECHALA BELIEVES THERE IS A SHARP EDGE INSIDE THE TUBE WHICH CAUSED THIS DAMAGE TO OUR SCOPE". NO PATIENT INVOLVEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "WE CURRENTLY USE YOUR SHERIDAN DUEL LUMEN ETT TUBES FOR OUR THORACIC CASES. TODAY WE HAD AN UNFORTUNATE ISSUE ARISE WITH ONE OF YOUR TUBES. DR. (B)(6), WHO USES THESE TUBES WEEKLY, INSERTED THE FLEXIBLE INTUBATING SCOPE INTO THE TUBE, AND AS IT WENT DOWN THE TUBE, A PIECE OF THE SCOPES COATING WAS CUT OFF. DR. (B)(6) BELIEVES THERE IS A SHARP EDGE INSIDE THE TUBE WHICH CAUSED THIS DAMAGE TO OUR SCOPE". NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419380 HUDSON ET TUBE, SHER-I-BRONCH, LS, 37 FR TUBE, TRACHEAL/BRONCHIAL, DIFF CBI TELEFLEX MEDICAL IPN048996 73C2100395 14026704617408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SCOPE.| SCOPE.| SCOPE