BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JET VENTILATION - HUNSAKER MON-JET VENTILATION TUBE

    MDR report key: 6145858 · Received December 5, 2016

    Report

    Report Number
    1045254-2016-00410
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 10, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    BTR
    UDI-DI
    00681490156431
    PMA / PMN Number
    K922880
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: 11/10/2016 . ADDITIONAL INFORMATION RECEIVED: THE DEVICE APPEARED NORMAL PRIOR TO INTUBATION. THE ANCHOR PIECE DETACHED WHILE REMOVING THE TUBE; FORCEPS WERE USED TO RETRIEVE THE DETACHED PIECE. THE PATIENT WAS UNDERGOING A MICROLARYNGOSCOPY POSTERIOR GLOTTOPLASTY. DATE RECEIVED BY MANUFACTURER: 12/06/2016. PRODUCT EVALUATION: FOR ANALYSIS, 1 UN-SEALED SAMPLE, PART NUMBER 7080100, FROM LOT NUMBER 0211286619, WAS RECEIVED; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. WHEN COMPARED TO THE ASSEMBLY DRAWING: VISUALLY, THE GREEN EXPANSION FINGERS WERE DETACHED FROM THE DISTAL END OF THE MAIN TUBE WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THERE WAS NO SIGNIFICANT DAMAGE TO THE PACKAGING TO INDICATE A CAUSE. WHEN VIEWED UNDER MAGNIFICATION, THE INCLUDED STYLETTE WAS STILL INSERTED, CONSISTENT WITH BEING CUT AT BOTH ENDS, AND BENT. THE JETTING TUBE WAS PULLED AWAY FROM THE MAIN TUBE AT THE DISTAL END. THE EXTENT OF PHYSICAL DAMAGE WOULD HAVE BEEN IMMEDIATELY NOTICEABLE PRIOR TO USE. THE INFORMATION MOST LIKELY INDICATES DAMAGE DURING HANDLING. METHOD: ACTUAL DEVICE EVALUATED. RESULTS: DEFORMATION PROBLEM. CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS NOT AVAILABLE; EVALUATION EXPECTED BUT NOT YET BEGUN. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE DEVICE APPEARED NORMAL PRIOR TO INTUBATION. THE ANCHOR PIECE DETACHED WHILE REMOVING THE TUBE; FORCEPS WERE USED TO RETRIEVE THE DETACHED PIECE. THE PATIENT WAS UNDERGOING A MICROLARYNGOSCOPY POSTERIOR GLOTTOPLASTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿GREEN END OF DEVICE HAS DISLODGED FROM THE MAIN PART OF THE TUBING. THE SURGEON NOTICED THIS IMMEDIATELY AND ASKED FOR AN INSTRUMENT TO GRAB THE DISLODGED ANCHOR PIECE AND SUCCESSFULLY PREVENT IT FROM FURTHER MIGRATING INTO THE PATIENT¿S LUNGS. NO FURTHER COMPLICATIONS RESULTED FROM THIS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796837 JET VENTILATION - HUNSAKER MON-JET VENTILATION TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR MEDTRONIC XOMED INC. 7080100 0211286619 00681490156431

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention