BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA RESERVOIR 1.5CM DOME, FLAT BOTTOM, SIDE

    MDR report key: 6610531 · Received June 5, 2017

    Report

    Report Number
    2648988-2017-00018
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    May 9, 2017
    Report Date
    May 15, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    NL8501214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 6/19/2017. METHOD: -DEVICE HISTORY REVIEW; -TREND ANALYSIS; -FAILURE ANALYSIS. REVIEW OF DEVICE HISTORY RECORD (DHR): DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 1165742 WAS REVIEWED. LOT NUMBER: 1165742; CATALOG NUMBER: NL8501214; DEVICE IDENTIFIER: (B)(4); PRODUCT IDENTIFIER: (B)(4); MFG (PACK) DATE: DECEMBER 15, 2016; EXPIRATION DATE: DECEMBER 31, 2021. NO ANOMALIES WERE FOUND DURING MANUFACTURING/PACKAGING PROCESS OF THE PRODUCT. REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM MAY 2015 TO MAY 2017, THERE IS NO OTHER COMPLAINT RELATED TO THE REPORTED CONDITION FOR THE SHUNT SYSTEMS PRODUCT FAMILY AND ACCESSORIES. (B)(4). ONE SAMPLE WAS RETURNED; THE FOREIGN MATTER WAS VISIBLE INSIDE THE SEALED PRODUCT. WHEN POUCH WAS OPENED, IT WAS CONFIRMED THAT THE PARTICLE WAS IN THE OUTSIDE POUCH (NOT IN CONTACT WITH THE PRODUCT). THE PARTICLE WAS A DARK, STRAIGHT FILAMENT ABOUT 2 MM LONG AND COULD BE, AS DESCRIBED BY THE CUSTOMER, A HAIR. THEREFORE, THE COMPLAINT IS CONFIRMED. CONCLUSION: THIS PRODUCT IS SUPPLIED IN A STERILE, NON-PYROGENIC, DOUBLE-WRAP PACKAGING SYSTEM. THE DOUBLE-WRAP SYSTEM FACILITATES THE PREFERRED METHOD OF STERILE PRODUCT TRANSFER FROM THE CIRCULATING AREA TO THE STERILE FIELD. INSIDE OF THE OUTER POUCH THERE WILL BE THREE (3) DIFFERENT COMPONENTS: AN IFU, ONE (1) POUCH CONTAINING THE INTEGRA CSF RESERVOIR, AND A SECOND POUCH CONTAINING THE VENTRICULAR CATHETER AND STYLET. THE HAIR WAS BETWEEN THE INNER COMPONENTS AND OUTER POUCH (NOT IN DIRECT CONTACT WITH THE PRODUCT).

    Description of Event or Problem · 1

    A HAIR WAS CONTAINED IN THE PACKAGE WHEN CHECKED BY THE DISTRIBUTOR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391949 INTEGRA RESERVOIR 1.5CM DOME, FLAT BOTTOM, SIDE N/A JXG INTEGRA NEUROSCIENCES PR 1165742

    Patients

    Seq Age Sex Outcome Treatment
    1