BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL EVD 10-110 W/O Y SITE

    MDR report key: 5314336 · Received December 21, 2015

    Report

    Report Number
    2648988-2015-00079
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    December 3, 2015
    Report Date
    December 3, 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

    THE PRODUCTS WERE NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) OF THE FINISH GOOD (FG) LOT # 1151963 WAS REVIEWED. THE FG LOT # 1151963 WAS RELEASED FOR DISTRIBUTION ON JUNE 17, 2015 IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURE OF THE FG LOT. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR FG LOT # 1151963 RELATED TO HAIR FOUND INSIDE PACKAGED PRODUCT OR ANY OTHER CONDITION. (B)(4). GIVEN THAT THE COMPLAINT UNIT HAS NOT BEEN RECEIVED FOR EVALUATION, THE REPORTED CONDITION (HAIR INSIDE OF PACKAGE) COULD NOT BE CONFIRMED. IT WAS REPORTED IN THE COMPLAINT RECORD THAT THE HAIR WAS FOUND INSIDE THE STERILE PACKAGE. THE LOCATION OF THE HAIR SUGGESTS THAT IT MOST LIKELY ENTERED THE POUCH DURING THE PACKAGING OPERATION.

    Description of Event or Problem · 1

    A HAIR WAS FOUND IN THE STERILE PACKAGE. THERE WAS NO PATIENT CONTACT, INJURY, OR DELAY IN SURGERY. THERE WAS NO PATIENT PREPPED FOR SURGERY. NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842341 SPECIAL EVD 10-110 W/O Y SITE N/A JXG INTEGRA NEUROSCIENCES PR 1151963

    Patients

    Seq Age Sex Outcome Treatment
    1