BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT

    MDR report key: 23157907 · Received September 26, 2025

    Report

    Report Number
    2023988-2025-00106
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 3, 2025
    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

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). STERILE DATE: (B)(6) 2023. DEVICE HISTORY REVIEW: UNIT HAS PASSED ALL THE REQUIRED TESTS. NO MANUFACTURING DEFECTS OR NON-CONFORMANCES OBSERVED. NO ASSOCIATED CAPAS. RISK MANAGEMENT REVIEW: A REVIEW OF (B)(4) MEDICAL DEVICE HAZARD ANALYSIS (REV 05), IDENTIFIES THE HAZARD SITUATION AS "6.4 SILICONE SHEARS OFF CATHETER TIP DURING INSERTION OR REMOVAL: A) SILICONE MATERIAL, TOLERANCING VS. STYLET, OR SILICONE ATTACHMENT INSUFFICIENT / NON-ROBUST FOR INTENDED USE B) PHYSICIAN INADVERTENTLY TEARS SILICON WITH STYLET OR CATHETER" BASED ON COMPLAINT OF "SILICONE TUBE RUPTURES." THE RISK LEVEL IS CONSIDERED LOW. THIS DETERMINATION IS BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER. ROOT CAUSE/FAILURE INVESTIGATION: THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR PROVIDE ADDITIONAL DETAILS REGARDING THE DEVICE. THE DEVICE HISTORY RECORDS SHOW SPECIFICATIONS WERE MET PRIOR TO RELEASE OF PRODUCT. COMPLAINT DATA WILL BE TRACKED AND TRENDED FOR RECURRENCE. NO FURTHER ACTION IS REQUIRED. FAILURE MODE: N/A - NOT RETURNED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). PER (B)(4) REV 05 CAMINO110-4 SERIES INTRACRANIAL PRESSURE/TEMPERATURE CATHETERS AND ACCESSORIES - RISK ANALYSIS SPREADSHEET, (RAS). HAZARD ID 6.4 SILICONE SHEARS OFF CATHETER TIP DURING INSERTION OR REMOVAL: A) SILICONE MATERIAL, TOLERANCING VS. STYLET, OR SILICONE ATTACHMENT INSUFFICIENT / NON-ROBUST FOR INTENDED USE B) PHYSICIAN INADVERTENTLY TEARS SILICON WITH STYLET OR CATHETER EFFECTS (HARM): INFLAMMATION; LOCAL TOXICITY; SYSTEMIC TOXICITY RESIDUAL RISK: MINOR. THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE BENEFIT OF USE OF THE ENTIRE PRODUCT OUTWEIGHS THE RISKS IDENTIFIED. REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER, AND AWAITING RESPONSE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - DURING THE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SILICONE TUBE OF THE VENTRICULAR CHANNEL WAS BROKEN.

    Description of Event or Problem · 0

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - DURING THE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SILICONE TUBE OF THE VENTRICULAR CHANNEL WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935521 MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT GWN NATUS MEDICAL INCORPORATED 1104HMT 118D01000800 00382830047531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other