BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMITORR VOLUME LIMITING EVD 30 ML

    MDR report key: 8304283 · Received February 5, 2019

    Report

    Report Number
    2648988-2019-00012
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 15, 2019
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K072929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THREE (3) LIMITORR UNITS WERE SENT INSIDE THE SAME PACKAGE WITH TWO (2) TRANSDUCERS ALSO INCLUDED WITH A STOPCOCK CONNECTOR STILL ATTACHED TO THEM. ONE OF THE UNIT HAD LOT NUMBER 3153423 / CATALOG # INS9030, BELONGING TO THIS REPORT. EACH OF THE THREE (3) UNITS HAD A BROKEN STOPCOCK CONNECTOR AS REPORTED IN THE COMPLAINT DESCRIPTION. THE DEVICE HISTORY RECORD (DHR) REVIEW DID NOT REVEAL ANYTHING THAT COULD CAUSE THE REPORTED CONDITION. THE LOT COMPLIED WITH ALL REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND PROCEDURES. THE COMPLAINT WAS CONFIRMED. THE REPORTED CONDITION WAS CONSISTENT IN THE POINT OF BREAKAGE. (B)(4).

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CLINICAL NURSE SPECIALIST REPORTED THAT THE INS9030 LIMITORR VOLUME LIMITING EVD 30 ML PRODUCTS EASILY BROKE WITH MINIMAL EFFORT. THE DATE OF THE EVENT WAS (B)(6) 2019. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 STATING THAT THE NURSE TESTED THE CONNECTOR PRIOR TO PLACING ON THE PATIENT. MINIMAL FORCE WAS USED AND IT BROKE. THERE WAS NO PATIENT CONTACT OR NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99806 LIMITORR VOLUME LIMITING EVD 30 ML N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1