MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT

Model Number	1104HMT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Micro ventricular bolt icp / temp.Monitoring kit - leakage of csf.No delay in surgery.No injuries.
Additional Manufacturer Narrative
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.
Event or Problem Description
Micro ventricular bolt icp / temp.Monitoring kit - leakage of csf.No delay in surgery.No injuries.

• Brand Name: MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT
• Common Device Name: MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego; CA 92121
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 19106407
• Report Number: 2023988-2024-00027
• Device Sequence Number: 7705127
• Product Code: GWN
• UDI-Device Identifier: 00382830047531
• UDI-Public: 00382830047531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 1104HMT
• Device Catalogue Number: 1104HMT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male