BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAS GZE 1X8 CISION DSG FOIL PK STRL

    MDR report key: 5226446 · Received November 16, 2015

    Report

    Report Number
    1018120-2015-00036
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 12, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR REVIEW BY THE CUSTOMER; HOWEVER, 1 PHOTO OF THE REPORTED CONDITION WAS SUBMITTED WITH THE COMPLAINT. THE PHOTO WAS EVALUATED FOR THE REPORTED CONDITION AND CLEARLY SHOWED A ZIGZAG PATTERN OF CUTS ON BOTH SIDES OF THE GAUZE; THE BOTTOM BEING THE SALVAGE EDGE OF THE GAUZE, WHERE THE MOST OBVIOUS LINTING IS PRESENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR LOT # 4120403X AND NO ABNORMAL PROCESS CONDITIONS WERE 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. THE GAUZE USED IN THIS PRODUCT IS OBTAINED FROM ANOTHER COVIDIEN FACILITY AND THEN THE BLEACHING PROCESS IS COMPLETED AT THE INVESTIGATING PLANT. ISSUES WITH STRINGING (LONG INDIVIDUAL STRANDS OF GAUZE BEING LEFT IN THE PACKAGE) WERE RECOGNIZED BY OPERATORS AS AN OPPORTUNITY FOR IMPROVEMENT. THIS WAS FOUND TO BE OCCURRING FROM THE STRAIGHT BLADES USED TO SLIT THE MATERIAL. TO ALLEVIATE THIS, THE SLITTERS WERE CHANGED TO PINKING BLADES THAT HAVE A ZIGZAG PATTERN. WHILE THESE NEW BLADES DID REDUCE STRINGING FOR ALL GAUZE TYPES, IT HAS SINCE BEEN DISCOVERED THAT THE GAUZE USED TO PRODUCT CODE 8884417601 AND ALL SIMILAR CODES PRODUCED WHICH USES A TIGHTER WEAVE THAT OTHER GAUZES USED IN THE FACILITY, CAUSED THE ZIGZAG PATTERN TO BE MORE VISIBLE AND COULD SUBSEQUENTLY CAUSE LINTING OF THE MATERIAL. LINTING IS DEFINED AS SHORT FIBERS THAT EASILY DETACH FROM THE GAUZE WHEN IN USE. TO ALLEVIATE THIS POTENTIAL ISSUE, THE SLITTERS REVERTED BACK TO USING THE STRAIGHT BLADES FOR THE TIGHTER-WOVEN GAUZE. QUALITY IN-PROCESS CHECKS HAVE NOT CHANGED. AS THE CORRECTIVE ACTION, A CHANGE HAS BEEN MADE TO DISCONTINUE THE USE OF PINKING BLADES AND TO RESUME USING THE STRAIGHT BLADES FOR SLITTING THE MATERIAL. THIS HAS ALREADY BEEN IMPLEMENTED AND NO FURTHER CORRECTIVE ACTION IS REQUIRED. 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. NO FORMAL CORRECTIVE ACTION PREVENTIVE ACTION HAS BEEN CREATED FOR THIS COMPLAINT. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES AND REVIEWED WITH PLANT MANAGEMENT.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2015. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE. THE CUSTOMER STATES WHEN THE PACKAGE WAS OPENED, THE GAUZE WAS EXCESSIVELY FRAYED WITH STRANDS OF MATERIAL HANGING LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758900 VAS GZE 1X8 CISION DSG FOIL PK STRL GAUZE SPONGE GDY COVIDIEN 8884417601 4120403X

    Patients

    Seq Age Sex Outcome Treatment
    1