MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED CODMAN* LUMBAR CATHETER KIT

Model Number 821707

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

Initial report (ref natus complaint#(b)(4)).Investigation results: complaint describes an event where a piece of the catheter was left inside the patient due to user error.Customer confirmed they caused the malfunction and wanted to know if the product could be left inside the patient or if additional intervention needed to be done to remove the extra piece.Clinical recommended to remove the foreign object.Customer confirmed the product is not related to product performance.Complaint form returned, confirmed at the time of the failure, there was no patient injury or delay in surgery.The affected product will not be returned.Review of product evaluation form shows no associated capas.Complaint history was reviewed for the previous two years and found 0 confirmed complaints, giving an incident rate of (b)(4).Review of medical device hazard analysis shows incident to identify as an acceptable risk.Acceptable risk associated with the complaint as per line 4.39 (b)(4) camino icp monitor risk analysis.Investigation result code: (b)(4) |eds products|no return of device for evaluation.

Event Description

Lumbar catheter (821707) distal tip sheared off in a patient due to user error.Complaint is not related to product performance.There was no patient injury or delay in surgery.

Manufacturer Narrative

Follow up report 001 (ref natus complaint#(b)(4)).Investigation results: complaint describes an event where a piece of the catheter was left inside the patient due to user error.Customer confirmed they caused the malfunction and wanted to know if the product could be left inside the patient or if additional intervention needed to be done to remove the extra piece.Clinical recommended to remove the foreign object.Customer confirmed the product is not related to product performance.Complaint form returned, confirmed at the time of the failure, there was no patient injury or delay in surgery.The affected product will not be returned.Review of product evaluation form shows no associated capas.Complaint history was reviewed for the previous two years and found 0 confirmed complaints, giving an incident rate of (b)(4).Review of medical device hazard analysis shows incident to identify as an acceptable risk.Acceptable risk associated with the complaint as per line 4.39 (b)(4) camino icp monitor risk analysis.Unable to perform device history record review as the customer did not report the device lot number.Manufacturing date is unable to be determined as customer did not provide the lot number.Investigation result code: san diego|eds products|no return of device for evaluation closure rationale:low safety risk of harm, individual complaint related to issue stated.Complaint will be included in trending data for further review and investigation if needed.

Event Description

Lumbar catheter (821707) distal tip sheared off in a patient due to user error.Complaint is not related to product performance.There was no patient injury or delay in surgery.

• Type of Device: CODMAN* LUMBAR CATHETER KIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego, 92121 CA
• MDR Report Key: 11736095
• MDR Text Key: 247698733
• Report Number: 2023988-2021-00007
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 821707
• Device Catalogue Number: 821707
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1