BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLET NEONATAL ENDOTRACHEAL TUBE GUIDE

    MDR report key: 3840861 · Received May 30, 2014

    Report

    Report Number
    1718887 -2014-00003
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 2, 2014
    Manufacturer
    CAREFUSION
    Product Code
    BSR
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED BY THE CUSTOMER, BUT IT WAS LOST IN THE SHIPPING/RECEIVING PROCESS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. A LOT NUMBER WAS NOT PROVIDED FOR EVALUATION. AS SUCH, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AT THIS TIME. A TWO YEAR COMPLAINT TREND WAS PERFORMED AND IT WAS OBSERVED THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED WHERE THE SHEATH CAME OFF OF THE STYLET WHILE ATTEMPTING TO INTUBATE. AS A PART OF THE MANUFACTURING PROCESS, STYLETS RECEIVE A 100% VISUAL INSPECTION BY OPERATORS TO ENSURE THAT THE SHEATHES ARE FULLY WELDED. ADDITIONAL SAMPLES ARE PULLED AND INSPECTED BY QC PERSONNEL DURING THE FINAL INSPECTION AND RELEASE PROCESS. WITH EACH WORK ORDER THAT IS MANUFACTURED, SUPERVISORS ARE RESPONSIBLE FOR VERIFYING THE TRAINING OF PERSONNEL INVOLVED IN THE JOB. ALL EMPLOYEES INVOLVED IN THE MANUFACTURING OF FINISHED STYLETS HAVE BEEN TRAINED ON THE APPROPRIATE OPERATING AND INSPECTION PROCEDURES. THERE WERE NO DISCREPANCIES NOTED FROM THE RECEIVING OR MANUFACTURING PROCESS THAT COULD IMPACT PRODUCT FUNCTIONALITY OR BE LINKED TO THE CONDITION REPORTED. THE STYLET SHEATH FOR (B)(4), IS A PURCHASED COMPONENT. THERE HAVE BEEN NO CHANGES TO THE MATERIAL SPECIFICATION SINCE JULY 2006. RECEIVING INSPECTION RECORDS FOR THE COMPONENT WERE REVIEWED FROM JANUARY 2012 TO PRESENT, AND ALL RECEIVED MATERIALS MET THE RELEVANT ACCEPTANCE CRITERIA. AT THIS TIME, A ROOT CAUSE CANNOT BE DETERMINED WITH NO SAMPLE AND NO LOT NUMBER AVAILABLE FOR EVALUATION. THIS ISSUE WILL BE RE-EVALUATED IF MORE INFORMATION BECOMES AVAILABLE IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ONE ULTRASLIP STYLET BLUE COVER CAME OFF THE METAL PART WHILE TRYING TO INTUBATE AN INFANTISSUE OCCURRED ON (B)(6) 2014 ACCORDING TO CUSTOMER. SALES REP (B)(4), INFORMED ON (B)(4) 2014 AND CUSTOMER WAS GIVE THE VITAL SIGNS CUSTOMER SUPPORT PHONE NUMBER. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON (B)(4) 2014: NO HARM TO THE PATIENT. THE BLUE COVER WAS COMING OFF  ABOUT 3 CM FROM THE TIP. ET TUBE WAS PULLED WHEN THE STYLET CAME OUT WITHOUT THE TIP. PT REINTUBATED WITH NEW ET TUBE AND STYLET. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 FROM CUSTOMER ((B)(6)): THE ISSUE WAS NOTICED AFTER THE STYLET WAS REMOVED. THE ET TUBE WAS REMOVED AND THE REST OF THE BLUE COVERING OF THE STYLET WAS STILL IN THE ET TUBE AND APPEARED TO BE COMPLETE. PATIENT WAS REINTUBATED WITH NEW SET-UP. NO OTHER MEDICAL INTERVENTION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318099 STYLET NEONATAL ENDOTRACHEAL TUBE GUIDE STYLET, TRACHEAL TUBE BSR CAREFUSION S5000N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention