MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NT821707, DRAINAGE KIT, LUMBAR

Model Number	NT821707
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Part nt821707 - the tip of a lumber catheter sheared while placing in a patient.
Additional Manufacturer Narrative
Initial report ref to natus complaint# (b)(4).Per (b)(4) rev 06 natus external drainage lumbar catheters - risk analysis spreadsheet hazard 1.1 - catheter tubing is cut by sharp inner edge of needle while accessing into lumbar spine and a catheter piece is left in the patient body.Effect (harm): adverse tissue reaction residual risk: moderate the hazard identified have been reduced as far as possible, and the residual risk for these hazards is mainly associated with patient having a adverese tissue reaction.The device is to be used in sterile condition and the ifu contains information about proper usage.In addition, techniques limiting cross contamination are already in place in the environment for use.The customer was provided with product return instructions.Further investigation to be carried out.

• Brand Name: NT821707, DRAINAGE KIT, LUMBAR
• Common Device Name: NT821707, DRAINAGE KIT, LUMBAR
• 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: 25157950
• Report Number: 2023988-2026-00059
• Device Sequence Number: 9581987
• Product Code: JXG
• UDI-Device Identifier: 00382830050531
• UDI-Public: 00382830050531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964923
• 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,Followup
• Report Date (Section B): 06/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/10/2026; 06/14/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown