MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Model Number	821731
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Product return follow up made 09-jan-2019, 15-jan-2019 and 22-jan-2019.
Event or Problem Description
Eds iii leaked at 3-way stop cock.

• Brand Name: CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8345691
• Report Number: 3010611950-2019-00008
• Device Sequence Number: 1598517
• Product Code: JXG
• UDI-Device Identifier: 10886704040910
• UDI-Public: 10886704040910
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K954021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: 821731
• Device Catalogue Number: 821731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other