MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM NERVOUS SYSTEM AND SHUNT CENTRAL COMPONENTS

Catalog Number INS-9030

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 11/04/2018

Event Type  Injury  

Event Description

The csf monitoring system had a port break off the stopcock.

• Brand Name: LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
• Type of Device: NERVOUS SYSTEM AND SHUNT CENTRAL COMPONENTS
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; plainsboro NJ 08536
• MDR Report Key: 8069506
• MDR Text Key: 127246931
• Report Number: MW5081208
• Device Sequence Number: 0
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: INS-9030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 11/13/2018 Patient Sequence Number: 1