BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPATCH 10152 PACK OF 500

    MDR report key: 5104539 · Received September 25, 2015

    Report

    Report Number
    2090010-2015-00038
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Report Date
    August 27, 2015
    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 COMPLETED ITS INTERNAL INVESTIGATION 09/25/2014. THE INVESTIGATION INCLUDED: METHOD: DHR REVIEW. REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. VISUAL INSPECTION. RESULTS: DEVICE HISTORY RECORD (DHR) OF THE FINISH GOODS LOT # 1143118 WAS REVIEWED. THE MANUFACTURING DATE IS 2014-2008 AND THE EXPIRATION DATE IS 2016-0208. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURE OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION (HAIR IN SEALED BLISTER). UPON REVIEW OF INTEGRA¿S COMPLAINT SYSTEM FROM JANUARY 2013 ¿ AUGUST 2015, A TOTAL OF (B)(6) COMPLAINTS (INCLUDING THIS ONE) RELATED TO THE REPORTED CONDITION (HAIR IN PACKAGE) FOR BIOPATCH PRODUCT FAMILY HAVE BEEN REPORTED. APPROXIMATELY (B)(4) UNITS HAVE BEEN RELEASED FOR DISTRIBUTION SINCE JANUARY 2013 ¿ AUGUST 26, 2015, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). ONE (1) UNOPENED UNIT FROM CATALOG 10152, ¿BIOPATCH® PROTECTIVE DISC WITH CHG¿ CORRESPONDING TO FG LOT # 1143118 WAS RECEIVED FOR EVALUATION IN ITS ORIGINAL PACKAGING. THE UNIT RECEIVED HAD A HAIR LOCATED ON TOP OF THE BIOPATCH FOAM. CONCLUSION: BASED ON FAILURE ANALYSIS, THE REPORTED CONDITION (HAIR IN SEALED BLISTER) WAS CONFIRMED. THE LOCATION OF THE HAIR INDICATES THAT IT MOST LIKELY ENTERED THE TRAY DURING THE PACKAGING OPERATION. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS OF BIOPATCH WERE IDENTIFIED BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD (DHR), CAPA'S, NCR'S AND RETAIN SAMPLES EVALUATION. CURRENT PROCESS CONTROLS ARE IN PLACE TO PREVENT OCCURRENCE AND DETECT THE REPORTED CONDITION (HAIR IN SEALED BLISTER). ISO CLASS 8 CLEAN ROOM MANUFACTURING FACILITY AND CLEANROOM GOWNING REQUIREMENTS (I.E. HAIRNETS, COVERALL, FACE MASKS, SHOE COVERS AND GLOVES) 100% VISUAL INSPECTION FOR FOREIGN MATTER (I.E. HAIR) BY MANUFACTURING AREA AND SAMPLING PERFORMED BY QUALITY CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT FOLLOWING A LVAD THE PATIENT WAS GIVEN A LVAD KIT FOR POST-OP AT-HOME CARE THAT INCLUDED BIOPATCH. THE PATIENT FOUND A HAIR IN THE UNOPENED BIOPATCH PRODUCT PACKAGING. NO ADVERSE CONSEQUENCE WAS REPORTED. ONE DEVICE IS BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635711 BIOPATCH 10152 PACK OF 500 BIOPATCH FRO INTEGRA NEUROSCIENCES PR 1143118

    Patients

    Seq Age Sex Outcome Treatment
    1