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

Model Number	NT821707
Medical Device Problem Codes	Break (1069); Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Part nt821707 - on (b)(6) 2024 single attempt of removal and on inspection, tip of catheter was noted to be sheared just distal to the last drainage holes on the catheter.No clinical signs, symptoms or conditions.
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Risk review: (b)(6) rev 05 natus external drainage lumbar catheters - risk analysis spreadsheet 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.Related capa# capa005401 further investigation to be carried out.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).Update to section d4.Expiration date of device.Update to section h4.Manufacturer date of device.Setrile date: (b)(6) 2024.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) 1 previously confirmed "integ-broke/disengage" 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 any further information regarding the alleged complaint.Failure mode: no device returned - unable to determine.
Event or Problem Description
Part nt821707 - on (b)(6) 2024 single attempt of removal and on inspection, tip of catheter was noted to be sheared just distal to the last drainage holes on the catheter.No clinical signs, symptoms or conditions.

• 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: 20509133
• Report Number: 2023988-2024-00071
• Device Sequence Number: 8078177
• 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): 11/26/2024

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: 11/23/2025
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Device Lot Number: 118001054906
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 60 KG