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

Model Number	NT821707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Nt821707 lumbar catheter placed in ir suite.Patient was taken to the floor and the drain was not draining.They discovered the catheter was not working.The neurosurgeon went to remove catheter in or and the catheter splintered into a few pieces.
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Risk review: doc-(b)(4).Rev 09 natus eds 3 external drainage system - risk analysis spreadsheet (ras) hazard 4.37 - eds male luer connector unable to secure to the catheter connector and the catheter disconnects effect (harm): delay in patient treatment, over drainage of csf and infection residual risk: medium no related capas.Further investigation to be carried out.
Additional Manufacturer Narrative
Follow report 001 ref to natus complaint # (b)(4).Update to sections - a2, a3a, b1, b5, d4, e4 expiration date and section h10.Per returned complaint form: the affected part is available to be returned.Further investigation to be carried out.
Event or Problem Description
Part nt821707, drainage kit, lumbar - over 70-year-old male with history of rectal cancer status post colectomy being worked up for possible normal pressure hydrocephalous.Patient underwent fluoroscopic guided intrathecal drain placement.Post procedure there was concern that the drain was not draining.Patient was brought back to procedure and underwent fluoroscopic guided intrathecal drain evaluation with removal that same day.Segmental defect within the lumbar drain catheter was identified.During removal the catheter broke.The intrathecal segment was successfully removed.No known harm to the patient.
Event or Problem Description
Part nt821707, drainage kit, lumbar - over 70-year-old male with history of rectal cancer status post colectomy being worked up for possible normal pressure hydrocephalous.Patient underwent fluoroscopic guided intrathecal drain placement.Post procedure there was concern that the drain was not draining.Patient was brought back to procedure and underwent fluoroscopic guided intrathecal drain evaluation with removal that same day.Segmental defect within the lumbar drain catheter was identified.During removal the catheter broke.The intrathecal segment was successfully removed.No known harm to the patient.
Additional Manufacturer Narrative
Follow report 002 ref to natus complaint # (b)(4).Sterile date: 12jun2024.Per (b)(4) rev 05 natus external drainage lumbar catheters - risk analysis spreadsheet (ras) hazard 3.22 - catheter shears upon removal by pulling on its exposed end.Effect (harm): surgical intervention required / delay in patient treatment (surgical delay - significant) residual risk: medium the hazards identified have been reduced as far as possible, and the residual risk for these hazards is mainly associated with overdrainage.The device's ifu states precautions in order to use the device.Hazards have associated warnings disclosed in the ifu / label.Risk outweighed by benefit of use of device.No associated capas device history record review: unit has passed all the required tests.No manufacturing defects or non-conformances observed.Complaint history review/trend analysis: (24 months review and percent of sales) (b)(4) previously confirmed "integ-improper function" 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.The device history records show specifications were met 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.

• 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 (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 20401960
• Report Number: 2023988-2024-00070
• Device Sequence Number: 3378740
• 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): 04/22/2025

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 Expiration Date: 11/30/2025
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Device Lot Number: 118001054907
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/06/2024; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male