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

Model Number	NT821707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).A questionnaire was sent to the customer, no reply to date.The lot number of the affected part is to be confirmed.Risk review: (b)(4) 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.No related capas.Further investigation to be carried out.
Event or Problem Description
Part nt821707 - lumbar drain catheter tip broke off.Upon removal of lumbar drain, fragment reported retained per ct at l3 l4.Device embedded in tissue or plaque.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint#: (b)(4).The lot number of the affected part was not provided by the customer.Complaint history review/trend analysis: (24 months review and percent of sales) 2 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).Capa: 005401 was noted to be related.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 - lumbar drain catheter tip broke off.Upon removal of lumbar drain, fragment reported retained per ct at l3 l4.Device embedded in tissue or plaque.

• 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: 20400244
• Report Number: 2023988-2024-00069
• Device Sequence Number: 3351649
• 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?: Yes
• Is this a Product Problem Report?: No
• 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): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/26/2024
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 63 KG