BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 5545551 · Received April 4, 2016

    Report

    Report Number
    2648988-2016-00014
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Report Date
    March 25, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON APRIL 27, 2016. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: EVALUATION OF RETURNED DEVICE; NO SAMPLES HAVE BEEN RECEIVED AT THE TIME OF THIS EVALUATION. THE REPORTED CONDITION CANNOT BE CONFIRMED. DHR REVIEW; THE FINISHED GOOD (FG) LOT # 1153168 WAS RELEASED FOR DISTRIBUTION ON AUGUST 31, 2015 IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURE OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION (BLUE TOP DELAMINATION). COMPLAINTS HISTORY; THERE IS NO OTHER COMPLAINT GENERATED TO LOT 1153168. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM (B)(6) 2014- (B)(6) 2016, A TOTAL OF (B)(4) COMPLAINTS (INCLUDING THIS ONE) RELATED TO DELAMINATION / ADHERING TO PICC FOR BIOPATCH PRODUCT FAMILY. (B)(4). CONCLUSION: NO PRODUCT MALFUNCTION OR ANY DEFECT THAT COULD BE ASSOCIATED TO LOT 1153168 MANUFACTURING PROCESS WAS IDENTIFIED. THE POLYURETHANE DISK CONTACTING THE WOUND ACTS LIKE A SPONGE THAT ABSORBS EXUDATE/MOISTURE FROM THE WOUND. WITH HIGHLY EXUDATIVE WOUNDS, THE MOISTURE FROM THE EXUDATE COULD SOFTEN THE MEDICAL GRADE ACRYLIC ADHESIVE AND MAKE THE BLUE NYLON REINFORCED FILM (SCRIM) MORE EASILY TO PEEL. IN THIS CASE, DETACHMENT OF THE BLUE NYLON REINFORCED FILM FROM THE BIOPATCH DISK IS POSSIBLE DUE TO THE PULLING FORCE EXERTED DURING THE REMOVAL OF THE TRANSPARENT FILM DRESSING THAT SECURES THE DEVICE AND BIOPATCH DISK TO THE SKIN. SINCE DETACHMENT OF THE BLUE NYLON REINFORCED FILM (SCRIM) IS MOST LIKELY TO OCCUR DURING REMOVAL OF THE BIOPATCH DISK, WHICH IS THEN DISCARDED, IT HAS NO IMPACT ON PATIENT CARE. AS PER APPLICATION PROCESS, BIOPATCH IS USED IN CONJUNCTION WITH OTHER PRODUCTS (E.G. SKIN PREP, TRANSPARENT FILM DRESSING) WHICH WHEN COMBINED MAY CONTRIBUTE TO BLUE FILM CATHETER ADHERENCE ISSUES. REGARDING THE SCRIM ¿SURROUNDING¿ THE PICC LINE IT IS MOST PROBABLE RELATED TO PRODUCT HANDLING WHEN REMOVING THE DRESSING. SINCE THE SCRIM IS ATTACHED TO THE TRANSPARENT FILM, IT CANNOT WRAP THE PICC LINE ON ITS OWN AND THUS IT IS MOST LIKELY TO BE WRAPPED AROUND THE PICC LINE WHEN HANDLING DURING TRANSPARENT FILM/DEVICE REMOVAL. WHEN SLIT OF DEVICE IS ALIGNED CORRECTLY WITH CATHETER, BIOPATCH WILL REMAIN ATTACHED TO THE TRANSPARENT FILM DRESSING AND REMOVAL WILL BE SIMULTANEOUS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE EXPERIENCED AN OCCURRENCE OF BIOPATCH ADHERING TO A PICC. THE BLUE PART STUCK TO THE DRESSING, IT SURROUNDED AND STUCK TO THE PICC LINE ALSO. THE DRESSINGS ARE CHANGED EVERY 7 DAYS. SCISSORS WERE USED TO CUT THROUGH THE TRANSPARENT DRESSING AND THE BIOPATCH TO REMOVE THE BIOPATCH. THERE WAS NO DRAINING FROM THE PICC LINE. EXUDATE WAS NOT DRIED SOLID AT THE TIME OF BIOPATCH REMOVAL. THE CUSTOMER IS UNABLE TO VERIFY IF THE SKIN PREP WAS ALLOWED TO DRY PRIOR TO THE BIOPATCH APPLICATION. VYGON (B)(4) COVER DRESSING WAS BEING USED OVER THE BIOPATCH. THERE HAVE BEEN NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202047 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR 1153168

    Patients

    Seq Age Sex Outcome Treatment
    1