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

Model Number	NT821707
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per md the lumbar drain is placed by anesthesia to prevent spinal cord ischemia.Upon drain removal by anesthesia it was noted the drain tip was not intact prompting ct.Per md imaging indicates retained catheter tip is in the subcutaneous tissue.Inquired about removal- drain was placed in a sterile environment and decision pending regarding removal.If pt stable with no complications from retained drain tip would prefer to remove as elective case after pt has stabilized.Md stated he would perform the removal since he is the primary surgeon for the pt.Patient went for a ct that confirm that in fact the piece is retained and requires surgery to remove.On (b)(6) ct results: retained 5.5 cm dural long lumbar drain fragment at the l2-l3 level extending from the posterior paraspinal space ventrally into the bony spinal canal and likely within the thecal sac at the level of l2-l3.
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Related to mdr report: # mw5171578.Per (b)(4) rev 05 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: moderate 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, warings, cautions, and precautions in order to use the device.Risk outweighed by benefit of use of device.Further investigation to be carried out.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint#(b)(4).No lot number information provided by the customer.No associated capas.Complaint history review/trend analysis: (b)(4).Risk management review: a review of (b)(4) medical device hazard analysis (rev 05), identifies the hazard situation as "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." the risk level is considered moderate.Based on complaint of "lumbar catheter tip retained in patient" this determination is based on the information received from the customer.Root cause/failure investigation: the customer did not return the device for evaluation or provide further information on the failure.Based on previously documented investigations, it is possible the silicone catheter was stretched and sheared by the beveled needle used to facilitate the insertion.Another possibility could be improper catheter preparation prior to placement; the catheter should be primed and flushed prior to placement - it could not be confirmed if this occurred.The instructions for use ((b)(6)) contain several warnings to help prevent this from occurring in the field.Without the return of the device, it could not be determined what led to the failure.Devices are fully tested prior to release of product.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
Per md the lumbar drain is placed by anesthesia to prevent spinal cord ischemia.Upon drain removal by anesthesia it was noted the drain tip was not intact prompting ct.Per md, imaging indicates retained catheter tip is in the subcutaneous tissue.Inquired about removal - drain was placed in a sterile environment and decision pending regarding removal.If pt stable with no complications from retained drain tip would prefer to remove as elective case after patient has stabilized.Md stated he would perform the removal since he is the primary surgeon for the pt.Patient went for a ct that confirmed that in fact the piece is retained and requires surgery to remove.May 22 ct results: retained 5.5 cm dural long lumbar drain fragment at the l2-l3 level extending from the posterior paraspinal space ventrally into the bony spinal canal and likely within the thecal sac at the level of l2-l3.

• 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: 22402446
• Report Number: 2023988-2025-00081
• Device Sequence Number: 8353094
• 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
• Report Date (Section B): 07/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic
• Patient Race: White