BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL EVD 10-110 W/O Y SITE

    MDR report key: 5348144 · Received January 6, 2016

    Report

    Report Number
    2648988-2015-00083
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Report Date
    December 11, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K062599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 05 FEB 2016. THE INVESTIGATION INCLUDED: METHODS: VISUAL EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINT HISTORY. RESULTS: VISUAL EVALUATION OF DEVICE: THE UNIT RECEIVED HAD A LONG HAIR SEALED WITHIN THE PRIMARY PACKAGING THAT WAS LOCATED ON TOP OF PRODUCT. THE DHR REVIEW HAS BEEN DEEMED SATISFACTORY. DATE OF MANUFACTURE: MAY 2015 AND EXPIRATION DATE: APR 2017. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURE OF THE FINISHED GOODS LOT. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT # 1151422 RELATED TO HAIR FOUND INSIDE PACKAGED PRODUCT OR ANY OTHER CONDITION. APPROXIMATELY (B)(4) UNITS OF MONITOR DEVICES HAVE BEEN SHIPPED FOR DISTRIBUTION FROM 2013 TO DECEMBER 14, 2015, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). THIS WAS DETERMINED BY DIVIDING THE NUMBER OF COMPLAINTS¿ UNITS IN THIS CATEGORY (2) BY THE NUMBER OF RELEASED UNITS FOR DISTRIBUTION. NO TREND HAS BEEN IDENTIFIED. CONCLUSION: THE CUSTOMER COMPLAINT INCIDENT "HAIR INSIDE POUCH" WAS CONFIRMED. THE LOCATION OF THE HAIR SUGGESTS THAT IT MOST LIKELY ENTERED THE POUCH DURING THE PACKAGING OPERATION. CAPA WAS ISSUED ON SEPTEMBER 25, 2015 DUE TO AN INCREASED TREND IN CONFIRMED INCIDENTS RELATED TO HAIR INSIDE PRODUCT PACKAGE CONTAINERS ACROSS THE DIFFERENT MANUFACTURING AREAS. INVESTIGATION FINDINGS OF CAPA DETERMINED THAT A PROBABLE ROOT CAUSE IS RELATED TO THE GOWNING APPAREL. AS PART OF CAPA PLAN ACTIVITIES, AN IMPROVEMENT TO THE CURRENT GOWNING APPAREL WILL BE IMPLEMENTED.

    Description of Event or Problem · 1

    A HUMAN HAIR WAS FOUND INSIDE OF THE POUCH WITH THE ACTUAL PRODUCT. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6385 SPECIAL EVD 10-110 W/O Y SITE N/A JXG INTEGRA NEUROSCIENCES PR 1151422

    Patients

    Seq Age Sex Outcome Treatment
    1