BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3612 LITE GLOVE 2X80

    MDR report key: 5090681 · Received September 21, 2015

    Report

    Report Number
    9612030-2015-00089
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    September 4, 2015
    Manufacturer
    COVIDIEN
    Product Code
    FMC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITION WAS PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE REPORTED CONDITION. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THREE CASES WITH UNUSED PRODUCT AND LOT NUMBER 5138101664X WERE RECEIVED FOR EVALUATION. THE SAMPLES WERE VISUALLY INSPECTED ACCORDING TO THE PRODUCT SPECIFICATIONS AND NONE OF THE SAMPLES DEMONSTRATED THE REPORTED CONDITION. THE REPORTED CONDITION COULD NOT BE CONFIRMED HOWEVER, BASED ON PREVIOUS EVALUATIONS ON SAMPLES REPORTED WITH A SIMILAR CONDITION THE POTENTIAL ROOT CAUSE THAT WAS DETERMINED FOR THIS ISSUE WAS A PROBLEM THAT OCCURRED DURING THE FORMING PROCESS IN WHICH THE FORMING TOOL REACHES A HIGH TEMPERATURE. DUE TO PROPERTIES OF THE MATERIAL, THE HEAT IS CONCENTRATED AT THE POINT OF CONTACT WITH THE FILM AND NOT DISSIPATED THROUGHOUT THE REST OF THE TOOLING THEREFORE IT DOES NOT BALANCE OUT. THIS MAY CAUSE THE FILM TO OVERHEAT AND COULD POTENTIALLY AFFECT THE STRENGTH OF THE MATERIAL. AS A CORRECTIVE ACTION THE MATERIAL USED FOR THE PLUG ASSISTS WAS CHANGED; THE DIFFERENCE IN THIS CHANGE IS ITS PROPERTIES, THE HEAT STABILIZED AROUND THE TOOLING (NOT ONLY THE CONTACT POINT WITH THE FILM) HAVING A LOWER IMPACT ON THE FILM FORMING PROCESS. AN ENGINEERING TEST REQUEST (ETR) WAS PERFORMED TO DETERMINE THE BEST TEMPERATURES TO FORM THE LITE GLOVE WITH THE NEW FORMING TOOL USING THE NEWER, IMPROVED MATERIAL. AFTER THE ETR WAS APPROVED, VALIDATION WAS PERFORMING TO CONFIRM THE PROPOSED PARAMETERS AND ENSURE THE QUALITY OF THE PRODUCT. A FORMAL CORRECTIVE AND PREVENTATIVE ACTION WAS IMPLEMENTED AS A RESULT. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THE MATERIAL OF SEVERAL LITE GLOVES RIPPED OPEN WHEN PUTTING THEM OVER THE LIGHT HANDLE. THE LITE GLOVES ARE TOO SMALL. THE ISSUE WAS NOTICED BEFORE THE PATIENT WAS IN THE OPERATING ROOM. THERE WAS NO PERSON INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623734 3612 LITE GLOVE 2X80 LITE GLOVE FMC COVIDIEN 31140257 51438101664X

    Patients

    Seq Age Sex Outcome Treatment
    1