BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-SLIP STYLET, ADULT

    MDR report key: 3903037 · Received June 30, 2014

    Report

    Report Number
    1718887 -2014-00004
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    November 1, 2013
    Report Date
    June 5, 2014
    Manufacturer
    CAREFUSION/VITAL SIGNS
    Product Code
    BSR
    PMA / PMN Number
    K914965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS AVAILABLE FOR EVALUATION. UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: UNFORTUNATELY, NO SAMPLE WAS SENT FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED DUE TO NO LOT NUMBER BEING REPORTED. DURING THE MANUFACTURING PROCESS REVIEW, IT WAS OBSERVED THAT ALL EMPLOYEES ARE TRAINED PER THE APPLICABLE PROCEDURE. WITH EACH WORK ORDER FOR STYLETS 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 APPLICABLE PROCEDURE, STYLET ASSEMBLY, AND ALL QUALITY CONTROL PERSONNEL RESPONSIBLE FOR THE INSPECTION AND RELEASE OF STYLETS HAVE ALSO BEEN TRAINED- FINAL INSPECTION ¿ STYLETS. A COMPREHENSIVE REVIEW OF THE DESIGN HISTORY RECORDS FOR S1000NEU HAS BEEN PERFORMED. THERE HAVE BEEN NO CHANGES RELATED TO ANY OF THE MATERIAL OR PROCESSING STEPS FOR THIS PRODUCT SINCE THE INITIAL RELEASE FOR PRODUCTION ON OCT 2009. FURTHER REVIEW EVIDENCES THAT THERE HAVE BEEN NO ISSUES RECORDED THAT RELATE TO THE REPORTED CONDITION. THERE IS NO SPECIFIC ISO STANDARD THAT INDICATES A TENSILE STRENGTH/MALLEABILITY REQUIREMENT FOR A STYLET. HOWEVER, LOT BASED VERIFICATION PROCESSES CERTIFY THAT PRODUCT MEETS SPECIFICATION STANDARDS FOR THE MATERIAL OF THE WIRE (C-1008) CONTAINED WITHIN THE PRODUCT. THE MATERIAL THAT GOVERNS THE TENSILE STRENGTH OF THE STYLET IS THE STYLET WIRE. A CERTIFICATE OF ANALYSIS (COA) IS RECEIVED WITH EACH LOT RECEIVED FROM THE SUPPLIER. THE COA INDICATES THAT THE MATERIAL OF THE WIRE IS ANNEALED CONDITIONED STEEL WIRE AS REQUIRED BY THE PRODUCT SPECIFICATION AND THE PRODUCT MEETS SPECIFICATION OF STANDARD ASTM A-510. BASED ON THE INVESTIGATION AND WITHOUT A SAMPLE, PER THE DATA REVIEWED, THE PRODUCT MEETS THE DEFINED SPECIFICATION. CAREFUSION WILL CONTINUE TO TREND AND MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: A PATIENT UNDERGOING SURGERY FOR A HERNIA IS PLANNED FOR GENERAL ANESTHESIA. DUE TO THE PATIENT'S HEIGHT AND WEIGHT DIFFICULT AIRWAY MANAGEMENT IS EXPECTED. PROCEDURE FOR THIS IS FOLLOWED AND RELEVANT EQUIPMENT FOR THIS IS IN THE ROOM. AS EXPECTED THE NORMAL WAY OF INTUBATION DOES NOT GIVE ACCESS TO THE TRACHEA. WITH THE MCGRATH LARYNGOSCOPE THEY GET VISUAL VIEW OVER TRACHEA, WHEN TRYING TO INTUBATE WITH THE GE STYLETTE IT LOOSES THE DESIRED SHAPE AND MAKES THE INTUBATION IMPOSSIBLE, THIS HAPPENS IN 3 ATTEMPTS. THE PATIENT IS THEN INTUBATED FINE WITH A DIFFERENT BRAND STYLET. THE PATIENT IS MANUALLY VENTILATED DURING THE WHOLE EPISODE, AND THERE HAS NOT BEEN ANY DESATURATION REPORTED. NO ACTIONS TAKEN LOCALLY, THIS IS REPORTED TO THE (B)(4) AS CASE (B)(4). THIS CASE HAS BEEN GOING AROUND IN DIFFERENT SYSTEMS- GE/ (B)(4). THE ISSUES IS THE SAME AS IN TRACK WISE : -(B)(4), IS TOO SOFT AND LOOSES THE DESIRED SHAPE, IN SITUATIONS WITH DIFFICULT AIRWAY MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381156 ULTRA-SLIP STYLET, ADULT STYLET, TRACHEAL TUBE BSR CAREFUSION/VITAL SIGNS S1000NEU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention