BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE

    MDR report key: 5442543 · Received February 17, 2016

    Report

    Report Number
    2648988-2016-00008
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Report Date
    January 28, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 08MAR2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: THE RETURNED SAMPLE SHOWED THAT THE GREEN STRIPE TUBING WAS NOT DETACHED FORM THE CONNECTOR TO THE STOPCOCK, BUT BROKEN OR TORN AT THE JUNCTION. THE PART OF THE TUBE INSIDE THE STOPCOCK WAS STILL ADHERED TO THE CONNECTOR. THE SURFACE OF THE TUBE WHERE IT BROKE OFF LOOKS ROUGH (NOT CLEAN CUT) AS IF TORN OR BROKEN. DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 1151426 WAS REVIEWED. NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. THIS LOT WAS RELEASED FOR DISTRIBUTION ON JUNE 04, 2015. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY. A REVIEW OF COMPLAINTS HISTORY FROM JANUARY 2014 TO JANUARY 2016 REVEALED NO OTHER COMPLAINT RELATED TO BREAKAGE OF THE PATIENT LINE AT THE STOPCOCK CONNECTOR. AS PER COMPLAINT DESCRIPTION THE DEVICE WAS ALREADY IN USE WHEN THE CONNECTION CAME APART (FOR HOW LONG WAS IT ATTACHED TO THE PATIENT WAS NOT REPORTED). THE CONDITION SEEMS TO HAVE A FIELD RELATED ROOT CAUSE AS DEVICE WAS NOT DETACHED FROM THE CONNECTION BUT INSTEAD IT WAS BROKEN; THEREFORE FAILURE IS ATTRIBUTABLE TO INAPPROPRIATE HANDLING WHERE EXCESSIVE BENDING AND/OR FORCE MAY HAVE BEEN APPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE ACCUDRAIN WAS ATTACHED TO THE PATIENT, THE CONNECTION CAME APART. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99232 INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE N/A JXG INTEGRA NEUROSCIENCES PR 1151426

    Patients

    Seq Age Sex Outcome Treatment
    1