BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NT821731C, EDS 3, GEN LL, NO CATHETER

    MDR report key: 18287603 · Received December 7, 2023

    Report

    Report Number
    2023988-2023-00048
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    August 5, 2023
    Report Date
    February 26, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    PMA / PMN Number
    K162437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF COMPLAINT (B)(4) PRODUCT RECALL. RISK REVIEW: PER DOC-035405 REV 07 RISK ANALYSIS SPREADSHEET, (RAS) - NATUS EDS 3 EXTERNAL DRAINAGE SYSTEM, HAZARD ID 3.7. CAUSE - PATIENT REACTION DUE TO BIO CONTAMINANTS OF EDS 3 SYSTEM. EFFECT (HARM) - INFECTION. RESIDUAL RISK - MEDIUM. THE HAZARD IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS IS MAINLY ASSOCIATED WITH PATIENT HAVING A BIOLOGICAL REACTION. THE DEVICE IS STERILE AND PACKED IN MANUFACTURING. THE DEVICE IS TO BE USED IN STERILE CONDITION AND THE USER MANUAL CONTAINS INFORMATION ABOUT PROPER USAGE. IN ADDITION, TECHNIQUES LIMITING CROSS CONTAMINATION ARE ALREADY IN PLACE IN THE ENVIRONMENT FOR USE. NO DEVICE HISTORY REVIEW AVAILABLE FOR THIS PRODUCT. NO ASSOCIATED CAPAS FOUND. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 0 CONFIRMED COMPLAINTS, GIVING A FAILURE RATE OF 0.00%. FINAL REVIEW AND APPROVAL OF INVESTIGATION DETAILS WAS CARRIED OUT AND THIS COMPLAINT CASE IS NOW CLOSED. IT HAS BEEN CONFIRMED THAT THE AFFECTED PART WILL NOT BE RETURNED FOR EVALUATION. LOT NUMBER OF THE PART WAS NOT PROVIDED. FAILURE CONFIRMED: NO. INVESTIGATION RESULT CODE: SAN DIEGO/EDS PRODUCTS/NO RETURN OF DEVICE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). REF TO RES# 93550 PRODUCT RECALL. IT HAS BEEN CONFIRMED THAT THE AFFECTED PART WILL NOT BE RETURNED FOR EVALUATION. LOT NUMBER OF THE PART WAS NOT PROVIDED. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    NATUS EDS3 DRAINAGE SYSTEM & COLLECTION BAG - SINCE JUNE WE HAVE SEEN FIVE MENINGITIS INFECTIONS (PREVIOUS INCIDENCE 1 OR 2 A YEAR) IN EVD PATIENTS. UNFORTUNATELY, WE DO NOT RECORD THE SERIAL OR LOT NUMBERS. THESE CASES HAVE OCCURRED DURING A PERIOD WHERE WE WERE USING YOUR DEVICES, INCLUDING LOT NUMBERS SUBJECT TO YOUR VOLUNTARILY RECALL 11/29/2023. PATIENT EVD INSERTED (B)(6) 2023. ON (B)(6) HE HAD PURULENT CSF WHICH SHOWED GNR AND GREW KLEBSIELLA AEROGENES. HE WAS TREATED FOR VENTRICULITIS/MENINGITIS. REVISION/MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 0

    NATUS EDS3 DRAINAGE SYSTEM & COLLECTION BAG - SINCE JUNE WE HAVE SEEN FIVE MENINGITIS INFECTIONS (PREVIOUS INCIDENCE 1 OR 2 A YEAR) IN EVD PATIENTS. UNFORTUNATELY, WE DO NOT RECORD THE SERIAL OR LOT NUMBERS. THESE CASES HAVE OCCURRED DURING A PERIOD WHERE WE WERE USING YOUR DEVICES, INCLUDING LOT NUMBERS SUBJECT TO YOUR VOLUNTARILY RECALL 11/29/2023. PATIENT EVD INSERTED (B)(6) 2023. ON 8/5, HE HAD PURULENT CSF WHICH SHOWED GNR AND GREW KLEBSIELLA AEROGENES. HE WAS TREATED FOR VENTRICULITIS/MENINGITIS. REVISION/MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221717 NT821731C, EDS 3, GEN LL, NO CATHETER NT821731C, EDS 3, GEN LL, NO CATHETER JXG NATUS MEDICAL INCORPORATED NT821731C

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other