MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821730C, EDS 3 GEN LL, WITH VENTRICULAR CATHETER

Model Number	NT821730C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Risk management review: per (b)(4) rev 09 risk analysis spreadsheet, (ras) - natus eds 3 external drainage system 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.The hazards identified have been reduced as far as possible, and the benefit of use of the entire product outweighs the risks identified.No related capas.Further investigation to be carried out.
Event or Problem Description
Nt821730c - stopcock between collection chamber and bag broke when draining.Evd was placed (b)(6) (event happened on day 7 of drain being in place).
Event or Problem Description
Nt821730c - stopcock between collection chamber and bag broke when draining.Evd was placed (b)(6) (event happened on day 7 of drain being in place).
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).Sterile date of affected part - (b)(6) 2024.Device history review: unit has passed all tests with acceptable results.Complaint history review/trend analysis: (24 months review and percent of sales) (b)(4) previously confirmed "integ-broke in use" complaints within the past two years.(b)(4) nt821730c units sold within past two years.Failure rate = (b)(4).Root cause/failure investigation: the stopcock is broken at the lever of the wall which is used to turn the stopcock into a closed or open position.The breakage of the components indicates that the user turned the stopcock with a tool instead of by hand leading to excessive torque applied.Failure mode: confirmed / stopcock breakage during use.

• Brand Name: NT821730C, EDS 3 GEN LL, WITH VENTRICULAR CATHETER
• Common Device Name: NT821730C, EDS 3 GEN LL, WITH VENTRICULAR CATHETER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego; 92121
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 20887853
• Report Number: 2023988-2024-00093
• Device Sequence Number: 7921994
• Product Code: JXG
• UDI-Device Identifier: 00382830050548
• UDI-Public: 00382830050548
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 06/19/2025
• Device Model Number: NT821730C
• Device Catalogue Number: NT821730C
• Device Lot Number: 118000999800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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: 69 YR
• Patient Sex: Female