BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLT POSITIONING KIT

    MDR report key: 3802983 · Received May 2, 2014

    Report

    Report Number
    1282497-2014-00033
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    TRIDIEN MEDICAL
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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# 14092. THERE WERE NO MANUFACTURING ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT NOTED IN THE DHR. SAMPLES WERE RECEIVED FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND SHOWED THAT THE STRAPS WERE NOT PROPERLY ATTACHED TO THE PAD. AFTER TESTING ALL POSSIBLE CONDITIONS TO REPLICATE THE FAILURE, THE EXACT ROOT CAUSE FOR 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 THE 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 THAT THE PT SLID OR SHIFTED THREE TO FOUR INCHES FROM THE PLACE THEY WERE POSITIONED, AND THAT THEY OBSERVED THAT THE BLACK STRAP BECAME UNATTACHED DURING THE PROCEDURE. THE PROCEDURE WAS PROLONGED BY A SHORT AMOUNT OF TIME (IT WAS NOT TIMED, BUT ESTIMATE LESS THAN 5 MINUTES) WHILE THE OPERATING ROOM TABLE WAS RAISED TO THE FLAT POSITION TO CONFIRM THAT THE PT HAD SHIFTED AND TO TRY TO DETERMINE IF HE WOULD SHIFT MORE. THE DECISION WAS MADE BY THE DOCTORS AND OTHER CLINICAL STAFF IN THE OPERATING ROOM TO RETURN THE PT TO THE TRENDELENBURG POSITION AND CONTINUE THE SURGERY. THE SURGERY WAS A LAPAROSCOPIC ABDOMINAL SURGERY. THERE WAS NO HARM TO THE PT AND NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265332 SLT POSITIONING KIT POSITIONING FOAM CBH TRIDIEN MEDICAL 31151090 14092

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK