BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NT821731C, EDS 3, GEN LL, NO CATHETER

    MDR report key: 19311367 · Received May 14, 2024

    Report

    Report Number
    2023988-2024-00035
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 30, 2024
    Report Date
    October 17, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    PMA / PMN Number
    K162437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). RISK REVIEW: PER (B)(4) REV 08 RISK ANALYSIS SPREADSHEET, (RAS) - NATUS EDS 3 EXTERNAL DRAINAGE SYSTEM HAZARD ID 4.40; CAUSE - LEAKAGE FROM THE STOPCOCK. EFFECT (HARM) - INFECTION. RESIDUAL RISK: MEDIUM; THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE BENEFIT OF USE OF THE ENTIRE PRODUCT OUTWEIGHS THE RISKS IDENTIFIED. NO RELATED CAPAS. THE CUSTOMER CONFIRMED THEY STILL HAVE THE DRAIN BUT THEY DID NOT PROVIDE THE LOT NUMBER. THE CUSTOMER WAS REQUESTED TO RETURN THE AFFECTED PRODUCT FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). COMPLAINT HISTORY REVIEW/TREND ANALYSIS: (24 MONTHS REVIEW AND PERCENT OF SALES) 4 PREVIOUSLY CONFIRMED "INTEG-TIGHTEN/HOLD/LOCK" COMPLAINTS WITHIN THE PAST TWO YEARS. 44,454 NT821731C UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE = 0.01% ROOT CAUSE/FAILURE INVESTIGATION: THE BROKEN SYSTEM STOPCOCK HAS A LARGE CRACK ON THE WALL. THE BREAKAGE OF THE COMPONENTS INDICATES THAT THE USER APPLIED EXCESSIVE TORQUE WHEN OPERATING THE STOPCOCK WHILE SIMULTANEOUSLY USING AGGRESSIVE CLEANING AGENTS THAT DEGRADE THE POLYCARBONATE MATERIAL. THIS COMBINATION LEADS TO BOTH PHYSICAL STRESS ON THE STOPCOCK AND MATERIAL DETERIORATION, INCREASING THE LIKELIHOOD OF FAILURE. THERE COULD ALSO BE A POTENTIAL CHANCE THAT THE USER MAY HAVE CROSS-THREADED THE STOPCOCK WITH AN EXTERNAL DEVICE/COMPONENT, RESULTING IN MISALIGNMENT AND INCREASED STRESS. IT SEEMS THAT THE USER POSSIBLY TRIED TO REMOVE SOMETHING FROM THE STOPCOCK WITH A TOOL AND APPLIED EXCESSIVE FORCE ON THE WALL. FAILURE MODE: CONFIRMED / STOPCOCK BREAKAGE DURING USE.

    Description of Event or Problem · 0

    NT821731C - PATIENTS EVD WAS LEAKING WHEN NURSE WENT TO DRAW CSF LABS. NO INJURIES.

    Description of Event or Problem · 0

    NT821731C - PATIENTS EVD WAS LEAKING WHEN NURSE WENT TO DRAW CSF LABS. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618557 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 NA Unknown