BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL EVD 10-110 W/O Y SITE

    MDR report key: 6993074 · Received November 1, 2017

    Report

    Report Number
    2648988-2017-00048
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 3, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K062599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 15DEC2017. TWO SP0090 UNITS WERE RECEIVED; ONE WAS LOT 1170022 AND THE OTHER WAS 1170281. THE ONE FROM LOT 1170281 HAD THE INJECTION PORT DISCONNECTED FROM THE STOPCOCK WHILE 1170022 WAS STILL ATTACHED TO THE STOPCOCK. SINCE 1170022 INJECTION PORT WAS STILL ATTACHED, IT WAS PROCEEDED TO TWIST IT OFF FROM THE STOPCOCK. NO ADHESIVE IS PLACED TO THE INJECTION PORT; THEREFORE, IT CAME OFF AS EXPECTED. DOCUMENTS AND LOGS REVIEWED FOR LOTS 1170022 AND 1170281 DID NOT REVEAL ANYTHING THAT COULD CAUSE THE REPORTED EVENTS. NO DEVIATIONS, EVENTS, AND/OR REWORK WERE RECORDED FOR LOTS 1170022 AND 1170281; THE LOTS COMPLIED WITH ALL REQUIREMENTS AS SPECIFIED IN THE RESPECTIVE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. LOT NUMBER: 1170022. MANUFACTURING (PACK) DATE: JANUARY 20, 2017. EXPIRATION DATE: DECEMBER 31, 2018 . LOT NUMBER: 1170281. MANUFACTURING (PACK) DATE: FEBRUARY 07, 2017. EXPIRATION DATE: JANUARY 31, 2019. NO DEFECT WAS FOUND ON PRODUCT: THE PRODUCT IS AS PER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER BELIEVED THAT THERE MAY HAVE BEEN A MANUFACTURING CHANGE ON THE DEVICE. SHE STATED HISTORICALLY, THE PROXIMAL LUER LOCK WAS FUSED TO THE DRAIN AND NOW IT APPEAR TO COME OFF EASILY. THE DRAIN WAS DISCARDED AND REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774768 SPECIAL EVD 10-110 W/O Y SITE N/A JXG INTEGRA NEUROSCIENCES PR 1170022

    Patients

    Seq Age Sex Outcome Treatment
    1