BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMITORR VOLUME EVD 20ML

    MDR report key: 7382628 · Received March 29, 2018

    Report

    Report Number
    2648988-2018-00012
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    February 12, 2018
    Report Date
    March 12, 2018
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K072929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER VERIFIED THAT THERE WAS NO CSF LEAK DUE THE REPORTED PRODUCT PROBLEM. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW FOR LOT 1172935 DID NOT REVEAL ANYTHING THAT COULD CAUSE THE REPORTED CONDITION. OCCLUSION AND LEAK TESTS WERE PERFORMED AND ALL UNITS PASSED THE TEST. THE FAILURE ANALYSIS IS NOT POSSIBLE; THE CUSTOMER REPORTED THAT THE UNIT WAS DISCARDED. NO PICTURES WERE PROVIDED, ALTHOUGH MENTIONED IN THE EVENT DESCRIPTION. GIVEN THAT COMPLAINT UNIT WAS NOT RETURNED FOR EVALUATION, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND NO FURTHER ANALYSIS IS POSSIBLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS BECAUSE IT HAS BEEN DISCARDED BY THE CUSTOMER. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBER: 2648988-2018-00013.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH WITH UF/IMPORTER REPORT # (B)(4) THAT ON (B)(6) 2018, AN INS9020SP1 LIMITORR VOLUME EVD 20ML DRAIN SETUP WAS FOUND TO BE BROKEN AT THE CONNECTION SITE WITH NO OBVIOUS CAUSE NOTED. THERE WAS NO PATIENT INJURY REPORTED AND THE EVD SETUP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223436 LIMITORR VOLUME EVD 20ML N/A JXG INTEGRA NEUROSCIENCES PR 1172935

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR