BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISTEC SPG 4X4 NON ST 10S 16PLY

    MDR report key: 4579523 · Received March 7, 2015

    Report

    Report Number
    1018120-2015-00004
    Event Type
    Injury
    Date Received
    March 7, 2015
    Report Date
    February 12, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REPORT INDICATED THAT A RETURNED SAMPLE WAS NOT EXPECTED AND TO DATE A SAMPLE HAS NOT BEEN RECEIVED. THIS COMPLAINT WILL BE RE-OPENED SHOULD A SAMPLE BE RETURNED IN THE FUTURE. AS PART OF THE MANUFACTURING PROCESS, A DEVICE HISTORY RECORD IS GENERATED FOR THE LOT 14M028262X MEETING ALL ACCEPTANCE CRITERIA PRIOR TO RELEASE. THE EXACT ROOT CAUSE FOR THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER, EXCESSIVE LINTING MAY BE CAUSED BY AN IMPROPER EDGE FOLD CAUSING RAW EDGES OF THE GAUZE TO BE EXPOSED. THE SPONGES ARE DESIGNED TO HAVE THE EDGES FOLDED INWARD TO KEEP THE GAUZE FROM FRAYING OR LINTING. THERE IS A SENSOR TO DETECT THE PRESENCE OF A FOLD, HOWEVER THE SENSOR DOES NOT DETECT IF THE FOLD IS FOLDED IMPROPERLY. ADDITIONALLY, THE MANNER IN WHICH THIS SPONGE WAS USED IS UNKNOWN. IF THIS SPONGE IS OPENED TO A SINGLE OR DOUBLE PLY CUT EDGES WOULD BE DISPLAYED AND APPEAR FRAYED (OR LINTING) AS THIS IS A NATURAL CHARACTERISTIC OF GAUZE. THIS PRODUCT IS SOLD AS A 4X4, 16-PLY SPONGE AND IS INTENDED TO BE USED IN THIS MANNER. DURING THE MANUFACTURING PROCESS, THE TENSILE MACHINES ARE USED TO EVALUATE THE BREAK (TENSILE) STRENGTH OF THE VISTEC GAUZE WHICH WILL DETERMINE IF THE GAUZE IS WEAK. PER WORK INSTRUCTIONS, ACTION IS TAKEN WITH THE BREAK POINT OF THE VISTEC GAUZE IF BELOW THE REQUIREMENTS. THERE HAS BEEN NO ISSUE NOTED FOR WEAK GAUZE FROM THE AUTOBANDER MACHINES. THE SAMPLES TESTED FOR BREAK POINTS WERE FOUND TO BE WITHIN SPECIFICATION. EACH AUTOBANDER MACHINE HAS A SENSOR THAT DETECTS IF THE EDGE FOLD IS OUT AND THIS SENSOR SHUTS DOWN THE MACHINE IF THE EDGE FOLD IS OUT. THE SENSORS ARE CHALLENGED EACH SHIFT AND DURING PREVENTATIVE MAINTENANCE ACTIVITIES.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 03/07/2015. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 02/12/2015 THAT A CUSTOMER HAD AN ISSUE WITH A SPONGE. THE CUSTOMER STATES THE GAUZE IS FLAKING AND MATERIAL IS FALLING OUT. THE ISSUE WAS REPORTED ON THE EH PED LAP PACK. THERE WAS NO INJURY REPORTED.

    Description of Event or Problem · 1

    A FORMAL CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN CREATED TO ADDRESS THIS AND SIMILAR REPORTED CONDITIONS. ALSO, IT IS RECOMMENDED TO THE CUSTOMER THAT THE SPONGE IS NOT INTENDED TO BE USED IN A SINGLE OR DOUBLE PLY AS IT EXPOSES THE EDGES OF THE SPONGE. NO CHANGES TO THE QUALITY CONTROL SAMPLING PLANS ARE DEEMED NECESSARY. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES AND REVIEWED WITH PLANT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160111 VISTEC SPG 4X4 NON ST 10S 16PLY SPONGE GDY COVIDIEN 7148 14M028262X

    Patients

    Seq Age Sex Outcome Treatment
    1