BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 3899917 · Received June 27, 2014

    Report

    Report Number
    2032282-2014-00090
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: COSEAL IS NOT INTENDED AS A SUBSTITUTE FOR STANDARD SURGICAL HEMOSTATIC, SEALING AND ADHESION PREVENTION TECHNIQUES (US: VASCULAR SEALING ONLY). A CHANGE IN PRODUCT COLOR AFTER SPRAY APPLICATION IS NOT AN EXPECTED, KNOWN PROPERTY OF COSEAL. IF THIS WAS TO RECUR, AND PRODUCT IS SPRAYED INTO PATIENT THE GEL WOULD ADHERE TO TISSUE AND WOULD BE DIFFICULT OR IMPOSSIBLE TO BE REMOVED. AFTER CONSIDERATION FOR POTENTIAL HARMS AND WORST-CASE SCENARIOS, IT CANNOT BE EXCLUDED THAT AN ADVERSE HEALTH CONSEQUENCE WILL RESULT FROM THIS ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE INVESTIGATION OF THE SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CASE INFORMATION WAS RECEIVED AND THE CASE WAS RE-ASSESSED. BAXTER MEDICAL ASSESSMENT: BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE YELLOWISH TINT OF THE COSEAL HYDROGEL CLOT IS THE RESULT OF THE APPLICATION OF A TOO THICK LAYER OF PRODUCT. AFTER CONSIDERATION FOR POTENTIAL HARMS AND WORST-CASE SCENARIOS, NO ADVERSE HEALTH CONSEQUENCE IS EXPECTED TO RESULT FROM THIS ISSUE. BAXTER HAYWARD COMPLETED THE INVESTIGATION. COMPANION SAMPLES WERE AVAILABLE FOR EVALUATION. SAMPLE EVALUATION WAS PERFORMED AND THE PEG POWDER SHOWED NO SIGNS OF MELTING AND THE SAMPLES PASSED ALL FUNCTIONAL TESTING. THE REPORTED DISCOLORATION OBSERVED ON THE PRODUCT HAS BEEN EVALUATED AT BAXTER ROUND LAKE AND IT WAS DETERMINED THE YELLOW COLOR WAS A NORMAL TINT IN COSEAL AND THE MATERIAL PROPERTIES IN TERMS OF SETTING TIME, MATERIAL RIGIDITY, AND ELASTICITY WERE NOT DIFFERENT FROM TYPICAL PROPERTIES OF COSEAL. RETENTION SAMPLES FOR THE REPORTED LOT WERE ALSO INSPECTED AND NO ABNORMALITIES WERE FOUND AND ALL FUNCTIONAL TESTING PASSED. BATCH RECORD REVIEW WAS PERFORMED AND ALL RELEASE PRODUCT MET SPECIFICATIONS AND NO ABNORMALITIES WERE FOUND THAT WERE ASSOCIATED WITH THE REPORTED PROBLEM. NO TREND WAS IDENTIFIED. PER HAYWARD, AN ASSIGNABLE ROOT CAUSE DUE TO MANUFACTURING DEFECT COULD NOT BE DETERMINED AT THIS TIME, NO FURTHER ACTION IS REQUIRED. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY BAXTER SALES REP THAT DURING A COSEAL PRESENTATION, THE PRODUCT LOOKED A LITTLE YELLOW. COSEAL WAS PREPARED AND SPRAYED AND THE PRODUCT (WHICH IS A GEL-LIKE SUBSTANCE) SET WELL BUT IT WAS NOTED THE GEL LOOKED YELLOW IN COLOR. THE COLOR OF THE PEG IN THE SYRINGE DIDN¿T RAISE ANY CONCERNS PRIOR TO SPRAYING. NO PATIENT OR USER INJURY REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014: FUNCTIONAL EVALUATION OF A COMPANION SAMPLE OF THE REPORTED LOT WAS CONDUCTED BY DIR, RESEARCH FOR THE BAXTER HAYWARD FACILITY AND BAXTER SENIOR RESEARCH SCIENTIST BIOSURGERY (THE COMPLAINANT) AT BAXTER ROUND LAKE. IT WAS FOUND THAT THE REPORTED 'UNUSUAL COLOR' FOR THE COSEAL WAS ACTUALLY A YELLOW TINT THAT COSEAL SOMETIMES EXHIBITS WHEN DISPENSED IN A THICK LAYER, SO IT IS CONSIDERED THE YELLOW TINT OR A PALE YELLOW COLOR IS NOT UNUSUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377111 COSEAL SURGICAL SEALANT SEALANT, POLYMERIZING NBE BAXTER HEALTHCARE - HAYWARD HA140235

    Patients

    Seq Age Sex Outcome Treatment
    1