MAUDE Adverse Event Report: NATUS NEURO INCORPORATED EVD/CSF; CODMAN* LUMBAR CATHETER KIT

Model Number 821707

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Reference (b)(4).Product removed successfully from patient, no reports of further injury or surgical delay.Requests made for return of product.Additional information will be provided if product returns.

Event Description

Needle bent twice while attempting cannulation.

• Brand Name: EVD/CSF
• Type of Device: CODMAN* LUMBAR CATHETER KIT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: janessa boone ; 5955 pacific center boulevard; san diego, CA 92121 ; 6088298603
• MDR Report Key: 8672328
• MDR Text Key: 147194744
• Report Number: 3010611950-2019-00036
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2019

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
• Device Operator: Health Professional
• Device Model Number: 821707
• Device Catalogue Number: 821707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other