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

Model Number	NT821707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Numbness (2415); Foreign Body In Patient (2687)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When inserting the lumbar drain, the patient felt numbness down her leg.The drain was retracted to reposition.Upon removal of the drain, it was discovered part of the end of the catheter was missing.(apparently sheared off by access needle.They removed the access needle to check for missing fragment but did not see it.A new access needle was used, and new lumbar drain was placed.
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Per (b)(4) natus external drainage lumbar catheters - risk analysis spreadsheet (ras) hazard 1.5 - 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): surgical intervention.Residual risk: medium.The hazard identified have been reduced as far as possible, and the residual risk for this hazard is mainly associated with the surgical revision.The device's ifu contains the instructions, warnings, cautions, and precautions in order to use the device.Risk outweighed by benefit of use of device.No associated capas.Complaint history review/trend analysis: (24 months review and percent of sales) 1 previously confirmed "integ-broke in use" complaints within the past two years.(b)(4) nt821707 units sold within past two years.Failure rate = (b)(4).Root cause/failure investigation: the customer did not return the device for evaluation or provide additional information.No further action is required; complaints will be tracked and trended for recurring issues.Failure mode: no device returned - unable to determine.

• 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: 21915993
• Report Number: 2023988-2025-00031
• Device Sequence Number: 19879774
• 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): 04/27/2025

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: 12/13/2025
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Device Lot Number: 118001060901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Race: White