BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5 CM BIOPATCH WITH 4.0 MM CENTER HOLE WITH MULTILINGUAL IFU

    MDR report key: 6391367 · Received March 9, 2017

    Report

    Report Number
    2648988-2017-00005
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 16, 2017
    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

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON SEPTEMBER 19, 2017 RESULTS: EVALUATION OF RETURNED DEVICE; ONE SAMPLE OF LOT 1161649/ 44150 WAS RETURNED. THE SAMPLE HAD A STRAND OF HAIR (ONE) INSIDE THE PACKAGE; THEREFORE, THE COMPLAINT IS CONSIDERED CONFIRMED. DHR REVIEW; NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURING OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. CONCLUSION: NO MANUFACTURING FAILURE WAS FOUND IN THE DOCUMENTS REVIEWED AS PART OF THIS INVESTIGATION. POSSIBLE ROOT CAUSE MAY BE RELATED TO A COMBINATION OF CONDITIONS: APPAREL AND DETECTION FAILURE. A CORRECTIVE ACTION WAS OPENED IN SEPTEMBER 2015 DUE TO AN INCREASE IN CONFIRMED INCIDENTS RELATED TO HAIR FOUND INSIDE PRODUCT PACKAGE CONTAINERS. THE INVESTIGATION DETERMINED THAT THE PROBABLE ROOT CAUSE FOR THE CONFIRMED COMPLAINTS OF HAIR IN FINISHED PRODUCTS IS RELATED TO THE GOWNING APPAREL. AS PART OF THE CORRECTIVE ACTION PLAN ACTIVITIES, AN OPEN FACE HOOD WAS IDENTIFIED WHICH ENHANCES PROTECTION OF FACIAL HAIR. THE SOP WAS REVISED AND IMPLEMENTED ON 09/15/2016 (THIS LOT WAS MANUFACTURED IN APRIL 2016) TO INCLUDE THE USE OF THE OPEN FACE HOOD (SUBSTITUTING THE HAIRNET) IN ALL MANUFACTURING AREAS INCLUDING BIOPATCH.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON MARCH 8, 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: NO PHOTO WAS PROVIDED AND NO SAMPLE WILL BE RETURNED AS PART OF THIS COMPLAINT. THE COMPLAINT CANNOT BE CONFIRMED. DHR REVIEW; NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURING OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. COMPLAINTS HISTORY; FROM FEBRUARY 2015 - FEBRUARY 2017, THERE HAVE BEEN THREE (3) COMPLAINTS RELATED TO HAIR INSIDE THE PACKAGE FOR THE BIOPATCH PRODUCT FAMILY. (B)(4). CONCLUSION: THERE ARE PROCEDURAL CONTROLS TO PREVENT THIS TYPE OF CONDITION. MANUFACTURING PERFORMS A 100% INSPECTION AFTER BLISTER PACKAGING FOLLOWING INTEGRA PROCEDURES. NO MANUFACTURING FAILURE WAS FOUND IN THE DOCUMENTS REVIEWED AS PART OF THIS INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED SINCE NO RETURN SAMPLE WAS PROVIDED. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS MOMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE WAS ABOUT TO OPEN A BIOPATCH AND SHE NOTICED STRAIGHT AWAY A HAIR INSIDE THE PACKAGING ON THE BIOPATCH ITSELF. SHE TOOK A LOOK AT THE OTHER SAMPLES OF THE BOX BUT ALL THE OTHERS WERE FINE, NO HAIR. NO REPORTED PATIENT CONSEQUENCES. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172755 2.5 CM BIOPATCH WITH 4.0 MM CENTER HOLE WITH MULTILINGUAL IFU BIOPATCH FRO INTEGRA NEUROSCIENCES PR 1161649

    Patients

    Seq Age Sex Outcome Treatment
    1