BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIMITORR VOLUME EVD 20ML

    MDR report key: 7382627 · Received March 29, 2018

    Report

    Report Number
    2648988-2018-00013
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    February 23, 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

    THE RETURNED DEVICE HAD THE MANIFOLD STOPCOCK CONNECTOR BROKEN, COMPLETELY SEPARATED FROM THE STOPCOCK¿S MAIN BODY. THE CONNECTOR WAS STILL ATTACHED TO THE TRANSDUCER. THE ¿PATIENT-LINE¿ STOPCOCK IS THE SAME AS THE ONE ON THE MANIFOLD. IT WAS EXAMINED AND FOUND IN GOOD CONDITION (NOT BROKEN). PRESSURE WAS APPLIED WITH FINGERTIP TO THE CONNECTION PART OF THE STOPCOCK AND IT BROKE IN THE SAME MANNER AS THE MANIFOLD STOPCOCK. THE SAME WAS TRIED WITH THE OTHER TWO (2) ENDS OF THE STOPCOCK, BUT THESE DID NOT BREAK. THE INFORMATION PROVIDED IN THIS COMPLAINT DID NOT INCLUDE A LOT NUMBER, BUT THE RETURNED UNIT BELONGED TO LOT 1172935. DEVICE HISTORY RECORD (DHR) REVIEW FOR LOT 1172935 DID NOT REVEAL ANYTHING THAT COULD CAUSE THE REPORTED CONDITION. OCCLUSION AND LEAK TESTS WERE PERFORMED AS PER LIMITORR FLOAT ASSEMBLY TESTS: ALL UNITS PASSED THE TEST. THE COMPLAINT IS CONSIDERED CONFIRMED. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS MOMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS YET. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBER: 2648988-2018-00012.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2018, AN INS9020SP1 LIMITORR VOLUME EVD 20 ML BROKE AT THE CONNECTION SITE. THE DEVICE WAS TESTED BY THE NURSE PRIOR TO PLACING IT ON THE PATIENT. THERE WAS NO INJURY NOR IMPACT TO THE PATIENT. ANOTHER DEVICE WITH A DIFFERENT LOT NUMBER WAS USED AND THE PROCEDURE CONTINUED WITHOUT DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226488 LIMITORR VOLUME EVD 20ML N/A JXG INTEGRA NEUROSCIENCES PR 1172935

    Patients

    Seq Age Sex Outcome Treatment
    1