BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYGON ENDOTRACHEAL TUBE

    MDR report key: 5913859 · Received August 30, 2016

    Report

    Report Number
    2245270-2016-00058
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Report Date
    December 15, 2016
    Manufacturer
    VYGON SA
    Product Code
    BTR
    PMA / PMN Number
    K960795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE MALFUNCTION WAS OBSERVED SEVERAL MORE TIMES, AND WERE REPORTED TO VYGON. PLEASE REFERENCE THE BELOW MDR'S FOR MORE INFORMATION ON THE ADDITIONAL COMPLAINTS. THE 2245270-2016-00057 AND 2245270-2016-00059. THE MALFUNCTIONING DEVICE WAS RETURNED TO VYGON FOR EXAMINATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    THIS DEVICE MALFUNCTION WAS OBSERVED SEVERAL MORE TIMES, AND WERE REPORTED TO VYGON. PLEASE REFERENCE THE BELOW MDRS FOR MORE INFORMATION ON THE ADDITIONAL COMPLAINTS. 2245270-2016-00057, 2245270-2016-00059. A TOTAL OF 3 DEFECTIVE SAMPLES WERE RECEIVED FROM BATCH NUMBER 160514BB. THE ANALYSIS PERFORMED ON THE SUSPECT PARTS HAS SHOWN THAT THE SIZE OF THE EXTERNAL DIAMETER OF THE COMPONENT ARE AT THE MINIMUM TOLERANCE LIMIT OF THE SPECIFICATION FOR BATCH NUMBER 160514BB. THE ANALYSIS CONFIRMS THAT THERE IS A STACK UP TOLERANCE ISSUE WITH THESE COMPONENTS WHICH EXPLAINS THE LOOSE FIT BETWEEN COMPONENTS. THIS IS A DIRECT RESULT OF EITHER COMPONENT BEING AT THE OPPOSITE END OF THE SPECIFICATION AND YET EACH COMPONENT BEING WITHIN SPECIFICATION. WE CHECKED OUR COMPLAINT DATABASE FOR THE LAST 3 YEARS (2016,2015,2014) AND WE DID NOT FIND A SIMILAR CLAIM AS REFERENCED ABOVE. CORRECTIVE/PREVENTATIVE ACTION: NO CORRECTIVE ACTION HAS BEEN ISSUED AT THIS POINT. HOWEVER, BOTH VYGON FRANCE AND VYGON USA HAVE ENTERED THIS INCIDENT INTO OUR COMPLAINT LOGS AND WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.

    Description of Event or Problem · 1

    A COUPLE TIMES THE CUSTOMER NOTICED THAT A VYGON ETT SLIPPED OUT, WHEN THEY INSERTED IT BACK IN THEY NOTICED THE FIT WAS LOOSE AND NOT SNUG. THE CUSTOMER DID NOT NOTE THE SPECIFIC SIZE OR LOT NUMBER OF THE FAILED DEVICE. THE CUSTOMER SWAPPED OUT THE FAILED ETT FOR ANOTHER ONE THAT FIT.

    Description of Event or Problem · 1

    A COUPLE TIMES THE CUSTOMER NOTICED THAT A VYGON ETT SLIPPED OUT, WHEN THEY INSERTED IT BACK IN THEY NOTICED THE FIT WAS LOOSE AND NOT SNUG. THE CUSTOMER DID NOT NOTE THE SPECIFIC SIZE OR LOT NUMBER OF THE FAILED DEVICE. THE CUSTOMER SWAPPED OUT THE FAILED ETT FOR ANOTHER ONE THAT FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565683 VYGON ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE BTR VYGON SA 5516.30 160514BB

    Patients

    Seq Age Sex Outcome Treatment
    1