MAUDE Adverse Event Report: NATUS NEURO INCORPORATED EDS-3 COMPLETE (STERILE) WITHOUT VENTRICULAR CATHETER

Model Number 821731C

Device Problem Failure to Disconnect (2541)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device from different lot tested.Unable to reproduce failure observed by complaint.

Event Description

Drainage bag broke off at the luer lock connection site.

• Brand Name: EDS-3 COMPLETE (STERILE) WITHOUT VENTRICULAR CATHETER
• Type of Device: EDS-3
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: janessa boone ; 3150 pleasant view road; middleton, WI 53562 ; 6088298603
• MDR Report Key: 8241534
• MDR Text Key: 132942438
• Report Number: 3010611950-2018-00003
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704040958
• UDI-Public: 10886704040958
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162437
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 821731C
• Device Catalogue Number: 821731C
• Device Lot Number: 206224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other