BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NT821731C, EDS 3, GEN LL, NO CATHETER

    MDR report key: 23644412 · Received November 25, 2025

    Report

    Report Number
    2023988-2025-00137
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 18, 2025
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    UDI-DI
    00382830050555
    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

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT# (B)(4). THE LOT NUMBER OF THE AFFECTED DEVICE WAS NOT PROVIDED BY THE CUSTOMER. CAPA005781 WAS OPENED TO INVESTIGATE THE INCREASE IN COMPLAINT RATES FOR THE EDS PRODUCT LINE. RISK MANAGEMENT REVIEW: A REVIEW OF (B)(4) MEDICAL DEVICE HAZARD ANALYSIS (REV 11), IDENTIFIES THE HAZARD SITUATION AS "5.12 STOPCOCKS: BROKEN, CRACKED/FRACTURED LUER FITTING." THE RISK LEVEL IS CONSIDERED MODERATE. BASED ON COMPLAINT OF "BROKEN LUER LOCK." THIS DETERMINATION IS BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER. ROOT CAUSE/FAILURE INVESTIGATION: THE PRODUCT WAS NOT RETURNED BY THE CUSTOMER, HOWEVER IMAGES PROVIDED BY THE CUSTOMER INDICATE THIS CASE HAD A DAMAGED LUER LOCK. THE BREAKAGE OF THE COMPONENT INDICATES THAT THE USER COULD HAVE APPLIED EXCESSIVE FORCE DURING THE CONNECTION/DISCONNECTION OF THE COLLECTION BAG. THERE COULD BE A POTENTIAL CHANCE THAT THE USER DID NOT FULLY SECURE THE COLLECTION BAG TO THE SPIN LUER LOCK OF THE EDS 3 SYSTEM OR MAY HAVE CROSS-THREADED THE TWO COMPONENTS, RESULTING IN MISALIGNMENT AND INCREASED STRESS ON THE LOCKING MECHANISM. SECTION "WARNINGS" ON PAGE 3 OF THE EDS 3 SYSTEM IFU (SD208650001 REV DA) GIVES DETAILS ON HANDLING THE EDS 3 SYSTEM SUCH AS FINGER TIGHTENING COMPONENTS AND NOT USING EXTERNAL TOOLS. FAILURE MODE: CONFIRMED/ LUER LOCK BREAKAGE DURING USE. CONFIRMED BY IMAGE ONLY.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT#: (B)(4). PER (B)(4) REV 11 RISK ANALYSIS SPREADSHEET - EDS 3 EXTERNAL DRAINAGE SYSTEM. HAZARD 4.9 - THE STOPCOCK AT THE BOTTOM OF THE BURETTE TUBE FAILS DURING THE OPERATION (UNABLE TO TURN THE STOPCOCK VALVE AND/OR BREAKAGE OF THE VALVE). EFFECT (HARM): OVER DRAINAGE/UNDER DRAINAGE OF CSF 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. CAPA: 005781 WAS OPENED TO INVESTIGATE THE INCREASE IN COMPLAINT RATES FOR THE EDS PRODUCT LINE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    NT821731C - BROKEN LUER LOCK CONNECTOR AT THE BASE OF THE BURETTE. NO INJURIES.

    Description of Event or Problem · 0

    NT821731C - BROKEN LUER LOCK CONNECTOR AT THE BASE OF THE BURETTE. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166547 NT821731C, EDS 3, GEN LL, NO CATHETER NT821731C, EDS 3, GEN LL, NO CATHETER JXG NATUS MEDICAL INCORPORATED NT821731C 00382830050555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown