BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT

    MDR report key: 19106407 · Received April 15, 2024

    Report

    Report Number
    2023988-2024-00027
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 19, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWN
    UDI-DI
    00382830047531
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). THE CUSTOMER CONFIRMED THAT THE AFFECTED PRODUCT WILL NOT BE RETURNED FOR EVALUATION. FURTHER REVIEW OF COMPLAINT DETAILS TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). UPDATE TO SECTION B3. INCLUDED EPIRY DATE SECTION D4, AND MANUFACTURING DATE TO SECTION H4. DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NO MANUFACTURING DEFECTS. 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%. REVIEW OF MEDICAL DEVICE HAZARD ANALYSIS SHOWS INCIDENT TO IDENTIFY AS AN ACCEPTABLE RISK. VIDEO OF THE FAILURE WAS PROVIDED, CSF LEAKAGE WAS OBSERVED AND CONFIRMED. CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION AFTER 2-3 FOLLOW UP ATTEMPTS. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, UNABLE TO CONFIRM ROOT CAUSE. THE VIDEO PROVIDED CONFIRMED DAMAGE TO LUER LOCK CAUSING LEAKAGE. ACCEPTABLE RISK AS PER (B)(4) CAMINO 110-4 SERIES CATHETER KITS-RISK ANALYSIS SPREADSHEET (RAS), HAZARD ID LINE 12.7, MODERATE RISK. FAILURE CONFIRMED: YES INVESTIGATION RESULT CODE: SAN DIEGO/CAMINO AND VTUN CATHETERS/PART IS CRACKED OR BROKEN.

    Description of Event or Problem · 0

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - LEAKAGE OF CSF. NO DELAY IN SURGERY. NO INJURIES.

    Description of Event or Problem · 0

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - LEAKAGE OF CSF. NO DELAY IN SURGERY. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469480 MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT GWN NATUS MEDICAL INCORPORATED 1104HMT 00382830047531

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male