BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPATCH 4150

    MDR report key: 4938359 · Received July 22, 2015

    Report

    Report Number
    2648988-2015-00060
    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 3RD 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. THE 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. (B)(4). CONCLUSION: (B)(4). 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 3 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
    477625 BIOPATCH 4150 BIOPATCH FRO INTEGRA NEUROSCIENCES PR 1151189

    Patients

    Seq Age Sex Outcome Treatment
    1