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

Model Number	NT821707
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint #(b)(4) the lot# information for the product was not provided.No associated capas.Complaint history review/trend analysis: (24 months review and percent of sales) 0 previously confirmed "integ-inoperable" complaints within the past two years.7,339 nt821707 units sold within past two years.Failure rate = (b)(4).Risk management review: a review of (b)(4) medical device hazard analysis (rev 05), identifies the hazard situation as "3.6 tuohy needle does not penetrate skin to access lumbar spine to guide catheter." the risk level is considered low.Based on complaint of "difficulty placing lumbar drain" this determination is based on the information received from the customer.Root cause/failure investigation: the customer did not return the device for evaluation.Feedback from customer indicated the tip of the 9cm tuohy needle in the kit may get dulled or curl backwards when placing the drain.Customer indicated this only occurs with several contact of bone and does not occur with more "straightforward" placements.No other complaints have been recorded for this issue.No further action is required; complaints will be tracked and trended for recurring issues.Failure mode: no device returned - unable to determine.
Event or Problem Description
Nt821707 - challenging lumbar drain placement.The tip of the 9cm tuohy needle in the kit may get dulled or curl backwards when placing the drain.No injuries.

• 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 92121
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego 92121
• MDR Report Key: 22206859
• Report Number: 2023988-2025-00056
• Device Sequence Number: 15370651
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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 Model Number: NT821707
• Device Catalogue Number: NT821707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown