BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NT821731C, EDS 3, GEN LL, NO CATHETER

    MDR report key: 20133132 · Received September 4, 2024

    Report

    Report Number
    2023988-2024-00064
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 31, 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). IT WAS CONFIRMED THE AFFECTED PRODUCT WILL BE RETURNED FOR EVALUATION. NO RELATED CAPAS. PER DOC-035405 REV 09 RISK ANALYSIS SPREADSHEET, HAZARD ID 5.12 CAUSE: STOPCOCKS: BROKEN, CRACKED/FRACTURED LUER FITTING. EFFECT (HARM)- DELAY IN PATIENT TREATMENT, CSF LEAKAGE AND OVER DRAINAGE OF CSF RESIDUAL RISK: MEDIUM. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). STERILE DATE: (B)(6) 2024. DEVICE HISTORY RECORD REVIEW: UNIT HAS PASSED ALL THE REQUIRED TESTS. NO MANUFACTURING DEFECTS OR NON-CONFORMANCES OBSERVED. COMPLAINT HISTORY REVIEW/TREND ANALYSIS: (24 MONTHS REVIEW AND PERCENT OF SALES) 5 PREVIOUSLY CONFIRMED "INTEG-BROKE IN USE" COMPLAINTS WITHIN THE PAST TWO YEARS. (B)(4) NT821731C UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE = (B)(4). ROOT CAUSE/FAILURE INVESTIGATION: THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. WITHOUT THE DEVICE IT IS IMPOSSIBLE TO DETERMINE ROOT CAUSE OF FAILURE. FAILURE MODE: NO DEVICE RETURNED - UNABLE TO DETERMINE.

    Description of Event or Problem · 0

    NT821731C, WHILE ATTEMPTING TO DRAW CSF LABS ON AUGUST 23RD 2024, IT WAS NOTICED THAT THE STOPCOCK ON THE EVD WAS CRACKED. NO INJURIES.

    Description of Event or Problem · 0

    NT821731C -WHILE ATTEMPTING TO DRAW CSF LABS ON (B)(6) 2024, IT WAS NOTICED THAT THE STOPCOCK ON THE EVD WAS CRACKED. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055338 NT821731C, EDS 3, GEN LL, NO CATHETER NT821731C, EDS 3, GEN LL, NO CATHETER JXG NATUS MEDICAL INCORPORATED NT821731C 118001028993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male