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

Model Number 821731

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Reference (b)(4).Product return follow up made 14-jan-2019, 21-jan-2019 and 28-jan-2019.

Event Description

Stopcock disconnected from tubing.

• Brand Name: CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• 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: 8345844
• MDR Text Key: 136856002
• Report Number: 3010611950-2019-00009
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704040910
• UDI-Public: 10886704040910
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K954021
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 821731
• Device Catalogue Number: 821731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/15/2019
• 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