BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPATCH 4150

    MDR report key: 4938355 · Received July 22, 2015

    Report

    Report Number
    2648988-2015-00059
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    June 26, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE 2ND OF 3 REPORTS FROM THE SAME CUSTOMER, SAME PRODUCT PROBLEM, DIFFERENT PRODUCT ID/LOT NUMBERS: 2648988-2015-00058; 2648988-2015-00059; 2648988-2015-00060. ADDITIONAL INFORMATION RECEIVED: CATHETER DISLODGEMENT IS A CONCERN. WHEN THE PRODUCT DELAMINATES, THE BLUE SCRIM IS WRAPPING AROUND THE CATHETER, WHICH MAY LEAD TO A POTENTIAL DISLODGEMENT. ALSO, THE CUSTOMER NORMALLY EXPERIENCES DELAMINATION WHEN THE PRODUCT IS SATURATED; HOWEVER, THEY NOW EXPERIENCE DELAMINATION EVEN WHEN THE PRODUCT IS DRY. DRESSING CHANGE PROTOCOL IS FOR 7 DAY DRESSING CHANGE, BUT DRESSINGS ARE CHANGED PRN IF NEEDED. THE SKIN PREP IS ALLOWED TO DRY PRIOR TO THE PRODUCT APPLICATION, PER PROTOCOL. 3M TRANSPARENT FILM DRESSING IS THE COVER DRESSING USED OVER THE PRODUCT. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 5AUG2015. THE ADDITIONAL INVESTIGATION ACTIVITIES INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: DEVICE HISTORY RECORD (DHR) OF THE FINISH GOOD (FG) LOT # 1151003 AND 1151189 WERE REVIEWED IN ORDER TO DETECT ANY ANOMALIES THAT COULD HAVE OCCURRED DURING THE MANUFACTURING PROCESS OF THE PRODUCT WHICH COULD HAVE CONTRIBUTED AND/OR BE RELATED WITH THE REPORTED CONDITION BEING INVESTIGATED (BLUE TOP DELAMINATION). FG LOT # 1151003 AND 1151189 WERE MANUFACTURED IN 2015-03 AND THE EXPIRATION DATE IS 2017-03. AS PART OF THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO DETECT DELAMINATION OF THE SCRIM FROM THE FOAM. A 100% VISUAL INSPECTION FOR PROPER ADHESION BETWEEN THE SCRIM AND FOAM IS PERFORMED BY MANUFACTURING PERSONNEL AS PER APPLICABLE PROCEDURE AND BY QUALITY CONTROL. THE FG LOT # 1151003 AND 1151189 WERE RELEASED FOR DISTRIBUTION ON APRIL 9, 2015 AND APRIL 13, 2015, RESPECTIVELY, IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURE OF THE FG LOTS THAT COULD BE RELATED TO THE REPORTED CONDITION (BLUE TOP DELAMINATION). SCAR RECORDS INITIATED FROM 2013 WERE REVIEWED FOR ANY SUPPLIER NONCONFORMANCE REGARDING THE BLUE FILM MATERIAL. NO SCAR¿S HAVE BEEN ISSUED DURING THIS PERIOD THAT COULD BE RELATED TO THE REPORTED CONDITION (BLUE TOP DELAMINATION). NO NCR¿S HAVE BEEN ISSUED THAT COULD BE RELATED TO THE REPORTED CONDITION (BLUE TOP DELAMINATION). CAPA (B)(4) WAS ISSUED ON JULY 9, 2013 TO RE-EVALUATE THE BIOPATCH MANUFACTURING PROCESS AND RAW MATERIALS IN ORDER TO LOOK FOR POTENTIAL CAUSES THAT COULD CONTRIBUTE TO THE ADHESION CONDITION ON DRY CHG DRUG LOADED POLYURETHANE FOAM. ALTHOUGH A ROOT CAUSE COULD NOT BE DETERMINED GIVEN THAT THE ADHESION CONDITION WAS NOT CONFIRMED AND NO CHANGES HAVE BEEN MADE TO THE FOAM, RAW MATERIALS OR TO THE BIOPATCH MANUFACTURING PROCESS, IT WAS FOUND THAT A SPECIFICATION FOR THE SCRIM PEEL ADHESION (TEST PERFORMED BY THE SUPPLIER) WAS NOT INCLUDED AS PART OF THE CERTIFICATE OF COMPLIANCE OF THE MATERIAL. CAPA WAS CLOSED ON NOVEMBER 26, 2014. AS A CORRECTIVE ACTION, (B)(4) WAS REVISED TO INCLUDE THE RECOMMENDED SPECIFICATION FOR PEEL ADHESION. THIRTEEN (13) RETAIN SAMPLES FROM FG LOT # 1151003 WERE EVALUATED AS PART OF THIS INVESTIGATION. ALL UNITS WERE VISUALLY AND PHYSICAL TESTED FOR FOAM/SCRIM ADHESION. ATTEMPTS WERE MADE TO REMOVE THE SCRIM FROM THE DRY FOAM. REMOVAL WAS NOT POSSIBLE GIVEN THAT GOOD ADHESION WAS OBSERVED BETWEEN THE TWO MATERIALS FOR ALL UNITS EVALUATED. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT #1151003 AND 1151189 REGARDING BLUE TOP DELAMINATION OR ANY OTHER CONDITION. UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM SINCE 2013, A TOTAL OF (B)(4) COMPLAINTS (INCLUDING THESE) RELATED TO ¿DELAMINATION¿ FOR BIOPATCH PRODUCT FAMILY HAVE BEEN REPORTED. (B)(4). CONCLUSION: BASED ON FAILURE ANALYSIS OF UNITS RECEIVED FOR EVALUATION, THE REPORTED CONDITION ¿BLUE TOP DELAMINATION¿ COULD ONLY BE CONFIRMED IN TWO UNITS: UNIT RECEIVED WITHOUT BLUE SCRIM AND BLUE SCRIM ADHERED TO DRESSING. UNITS RECEIVED CORRESPONDING TO FG LOT¿S 1151003 AND 1151189 DID NOT PRESENT THE CONDITION (BLUE TOP DELAMINATION); NO ISSUES INDICATING POOR ADHESION BETWEEN SCRIM AND FOAM WERE NOTICED BASED ON FAILURE ANALYSIS OF RETURNED UNITS. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS OF BIOPATCH WERE DETERMINED BASED ON THE REVIEW OF DHR, NCR'S, SCAR'S AND RETAIN SAMPLES EVALUATION. AS PART OF CAPA (B)(4), IT WAS FOUND THAT A SPECIFICATION FOR THE SCRIM PEEL ADHESION (TEST PERFORMED BY THE SUPPLIER) WAS NOT INCLUDED AS PART OF THE CERTIFICATE OF COMPLIANCE OF THE MATERIAL. THE BLUE NYLON FILM MATERIAL USED FOR THE MANUFACTURE OF FG LOT # 1151003 AND 1151189 WAS MANUFACTURED PRIOR TO CAPA (B)(4) IMPLEMENTATION ON NOVEMBER 26, 2014. IN ADDITION, THE ADHESIVE USED ON THE FILM MATERIAL IS DISPERSIBLE IN WATER. CONSEQUENTLY, AN OVERSATURATED DRESSING HAS THE POTENTIAL TO CAUSE DETACHMENT OF THE SCRIM MATERIAL FROM THE CHG DRUG LOADED POLYURETHANE FOAM. THIS OVERSATURATION CONDITION IS NOT RELATED TO A MALFUNCTION OF THE BIOPATCH DISK AND DOES NOT AFFECT THE DRUG RELEASE EFFECT OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    TOTAL OF 3 COMPLAINTS OPENED FOR THIS EVENT TO CAPTURE THE ISSUE/LOT NUMBERS. THIS IS REPORT 2 OF 3. IT WAS REPORTED BY THE SALES REP. THAT DURING DRESSING CHANGES, THE BLUE TOP IS DELAMINATING FROM THE FOAM AND WRAPPING AROUND THE CATHETER. THIS IS REPORTED TO BE HAPPENING "EVERY TIME", BUT NO SPECIFIC NUMBER OF OCCURRENCES HAS BEEN RECORDED. HE ALSO STATES THERE IS A DIFFERENCE IN THE FEELING OF THE DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED. NO PRODUCT HAS BEEN SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477302 BIOPATCH 4150 BIOPATCH FRO INTEGRA NEUROSCIENCES PR 1151003

    Patients

    Seq Age Sex Outcome Treatment
    1