MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821731C, EDS 3, GEN LL, NO CATHETER

Model Number	NT821731C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Nt821731c - stopcock failure.No injuries.
Additional Manufacturer Narrative
Initial report ref to natus complaint# (b)(4) per (b)(4) rev 14 risk analysis spreadsheet - eds 3 external drainage system hazard 5.12 - stopcocks: broken, cracked, or fractured luer fitting and/or hub effect (harm): delay in patient treatment, csf leakage and over drainage of csf residual risk: medium.Stopcock breakage may result in fluid leakage and require device replacement.Implemented risk controls mitigate potential harm, and the clinical benefits of eds 3 in safe and accurate csf drainage continue to outweigh the residual risk.Related to capa005781.Further investigation to be carried out.

• Brand Name: NT821731C, EDS 3, GEN LL, NO CATHETER
• Common Device Name: NT821731C, EDS 3, GEN LL, NO CATHETER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 25157952
• Report Number: 2023988-2026-00055
• Device Sequence Number: 15848444
• Product Code: JXG
• UDI-Device Identifier: 00382830050555
• UDI-Public: 00382830050555
• 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): 06/09/2026

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 Model Number: NT821731C
• Device Catalogue Number: NT821731C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown