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

Model Number	NT821707
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Related to mdr report: (b)(4).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.
Event or Problem Description
Nt821707 - on [redacted], ir [interventional radiology] physician reported unsuccessful fluoroscopically guided lumbar drain placement complicated by a short fragment of distal drain sheared off into posterior epidural space (small foreign body).Ct cath fragment retained 2.5cm and diameter of 0.2cm in right dorsal epidural spaced.Level l3-4.Procedure aborted and no safe way of percutaneous retrieval.Discussed with neurology md team.Discussed with patient and several family members at great length.On the next day [redacted], pt was taken to surgery for csf [cerebrospinal fluid] leak repair (unrelated to this event) and neurosurgeon was able to remove the retained drain fragment, but it was unfortunately discarded by surgery team.No harm or deviation in care.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).Sterile date of product 18 may 2024.Device history record review: unit has passed all the required tests.No manufacturing defects or non-conformances observed.No associated capas.Complaint history review/trend analysis: (24 months review and percent of sales) 1 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).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 "catheter fragment sheared off 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.Feedback from the customer indicated failure occurred during placement of lumbar drain, no additional details were provided on what may have led to shearing of catheter.Risk is captured in (b)(4) rev 05 natus external drainage lumbar catheters - risk analysis spreadsheet (ras.The patient was taken to surgery the next day and the fragment was removed successfully.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
Nt821707 - on [redacted], ir [interventional radiology] physician reported unsuccessful fluoroscopically guided lumbar drain placement complicated by a short fragment of distal drain sheared off into posterior epidural space (small foreign body).Ct cath fragment retained 2.5cm and diameter of 0.2cm in right dorsal epidural spaced.Level l3-4.Procedure aborted and no safe way of percutaneous retrieval.Discussed with neurology md team.Discussed with patient and several family members at great length.On the next day [redacted], pt was taken to surgery for csf [cerebrospinal fluid] leak repair (unrelated to this event) and neurosurgeon was able to remove the retained drain fragment, but it was unfortunately discarded by surgery team.No harm or deviation in care.

• 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: 22207557
• Report Number: 2023988-2025-00065
• Device Sequence Number: 6755927
• 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): 06/19/2025

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: 08/11/2025
• Device Model Number: NT821707
• Device Catalogue Number: NT821707
• Device Lot Number: 118001039912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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: 26 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White