BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE,HVT,8.0,NOVA PLUS

    MDR report key: 5470516 · Received March 1, 2016

    Report

    Report Number
    3003898360-2016-00181
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 18, 2016
    Report Date
    February 18, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ET TUBE, HVT, 8.0 NOVA PLUS (V5-10316) FOR INVESTIGATION. THE ET TUBE WAS RECEIVED IN ITS ORIGINAL PACKAGING; HOWEVER, THE POUCH WAS OPENED. IN ADDITION, THE CUSTOMER RETURNED ELEVEN SEALED BD SYRINGES FOR INVESTIGATION. SEVEN OF THE RETURNED SYRINGES ARE 10ML LUER LOCK SYRINGES. FOUR OF THE RETURNED SYRINGES ARE 10ML LUER LOCK SYRINGES WITH A BLUNT FILL NEEDLE ATTACHED. A VISUAL EXAM WAS PERFORMED ON THE ET TUBE AND NO DEFECTS WERE OBSERVED. THE FEMALE LUER OF THE BESPAK VALVE WAS MEASURED PER ISO 594-1:1986 USING A FEMALE LUER GAUGE (GA-1130-005-38). THE LUER TIP WAS FOUND TO BE WITHIN SPECIFICATION. ALL 11 OF THE RETURNED BD SYRINGES WERE ALSO TESTED USING A MALE LUER GAUGE (GA-TP-0057-003). ALL SYRINGE TIPS WERE FOUND TO MEET SPECIFICATION. THE RETURNED ET TUBE WAS FUNCTIONALLY TESTED USING A LAB INVENTORY 10ML LUER LOCK SYRINGE. THE SYRINGE WAS INSERTED INTO THE FEMALE LUER OF THE BESPAK VALVE. ONCE INSERTED, THE SYRINGE CONNECTION WAS FOUND TO BE SECURE. THE SYRINGE WAS DETACHED FROM THE LUER AND AIR WAS ASPIRATED INTO THE SYRINGE. THE SYRINGE WAS RECONNECTED TO THE LUER AND USING HAND PRESSURE, THE AIR IN THE SYRINGE WAS INJECTED THROUGH THE VALVE TO INFLATE THE CUFF. (CON'T) OTHER REMARKS: THE ET TUBE COULD BE INFLATED AND DEFLATED USING A LAB INVENTORY SYRINGE WITH NO FUNCTIONAL ISSUES FOUND. THE REPORTED COMPLAINT OF DIFFICULTY ATTACHING A SYRINGE TO THE ET TUBE INFLATION VALVE COULD NOT BE CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE RETURNED ET TUBE INFLATION VALVE AND THE RETURNED SYRINGES WERE FOUND TO BE WITHIN SPECIFICATION PER ISO 594-1: 1986 WHEN MEASURED WITH CALIBRATED LUER GAUGES. IN ADDITION, THE RETURNED ET TUBE WAS ABLE TO CONNECT TO A LAB INVENTORY SYRINGE FOR INFLATION AND DEFLATION WITH A SECURE CONNECTION. A DHR REVIEW WAS PERFORMED ON THE ET TUBE LOT NUMBER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. NO FUNCTIONAL OR DIMENSIONAL ISSUES WERE FOUND WITH THE RETURNED SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT USAGE WHEN THE ALLEGED ISSUE WAS DETECTED IS UNKNOWN. FROM THE PICTURE PROVIDED IT SEEMS TO BE A "DIFFICULT TO ATTACH SYRINGE". NO OTHER DEFECTS WERE OBSERVED. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES REQUIRED. FROM THE PICTURE PROVIDED IT SEEMS TO BE A "DIFFICULT TO ATTACH SYRINGE", THE COMPLAINT WAS UNABLE TO BE CONFIRMED WITH THE PICTURE ATTACHED, CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION & DETERMINE ROOT CAUSE. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES HAVING SOME DIFFICULTY ATTACHING THE 10ML SYRINGE TO THE PILOT TO INFLATE THE CUFF.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES HAVING SOME DIFFICULTY ATTACHING THE 10ML SYRINGE TO THE PILOT TO INFLATE THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127882 HUDSON ET TUBE,HVT,8.0,NOVA PLUS TRACHEAL TUBE BTR TELEFLEX MEDICAL 73D1500309

    Patients

    Seq Age Sex Outcome Treatment
    1