BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLT POSITIONING KIT

    MDR report key: 3803004 · Received May 2, 2014

    Report

    Report Number
    1282497-2014-00034
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    TRIDIEN MEDICAL
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR LOT# 14086. THERE WERE NO MANUFACTURING ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT NOTED IN THE DHR. NO SAMPLES WERE AVAILABLE TO BE RETURNED FOR INVESTIGATION BECAUSE THEY WERE DISPOSED OF BY THE CUSTOMER. EVEN THOUGH THE SAMPLES WERE NOT AVAILABLE, TESTING WAS PERFORMED AT THE SUPPLIER IN AN ATTEMPT TO REPLICATE THE REPORTED FAILURE. AFTER TESTING ALL POSSIBLE CONDITIONS, THE EXACT ROOT CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. THOUGH NO TEST COULD REPLICATE THE NON-CONFORMANCE, THE MOST LIKELY ROOT CAUSE CAN BE ATTRIBUTED TO A HIGH DEGREE OF VARIATION DURING THE GLUING PROCESS DUE TO LACK OF MANUFACTURING CONTROLS AND PROCESS METHODS. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO THE SUPPLIER. AS A CORRECTIVE ACTION, CHANGES WERE MADE TO REDUCE THE PROCESS VARIATION. VISUAL AIDS AND DETAILED TEMPLATES WERE CREATED TO ASSIST WITH THE VARIATION DUE TO OPERATORS. THE STANDARD OPERATING PROCEDURES WERE UPDATED WITH DETAILED INSTRUCTIONS AND ALL OPERATORS HAVE BEEN RETRAINED. A NEW ADHESIVE WITH STRONGER BOND PROPERTIES WAS IDENTIFIED AND VALIDATED. AS A PREVENTIVE ACTION, ONGOING MONITORING WILL INCLUDE PULL TESTING SAMPLES. THIS COMPLAINT WILL BE USED FOR TRENDING AND TRACKING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH POSITIONING FOAM. THE CUSTOMER REPORTS THE PT SHIFTED APPROX 2"-3" WHEN PUT INTO TRENDELENBURG POSITION. THE STRAP HAD WHITE GLUE ON IT AND THE STRAP SEPARATED FROM THE FOAM. THE CUSTOMER FURTHER REPORTS THAT THEY HAD TO REMOVE THE POSITIONER ONCE THE PT WAS INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265314 SLT POSITIONING KIT POSITIONING FOAM CBH TRIDIEN MEDICAL 31151090 14086

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK