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	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Part 821707 codman* lumbar catheter kit - while performing a lumbar drain at the bedside - a piece of the soft tubing was sheared and left in the thecal sac.The device did not do what it was supposed to do; device was hard to use.
Additional Manufacturer Narrative
Initial report ref to natus complaint (b)(4).Device identifier (udi number) : n/a.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.Further investigation to be carried out.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint#: (b)(4).Device sterile date: on (b)(6) 2024.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 is noted to be related, capa was closed in 2022.Device history record review: unit has passed all the required tests.No manufacturing defects or non-conformance's observed.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
Nt821707, drainage kit, lumbar while performing a lumbar drain at the bedside - a piece of the soft tubing was sheared and left in the thecal sac.The device did not do what it was supposed to do; device was hard to use.

• 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: 20509422
• Report Number: 2023988-2024-00073
• Device Sequence Number: 20862908
• 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): 11/27/2024

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: 11/09/2025
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Device Lot Number: 118001039913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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: 54 YR
• Patient Sex: Female