MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 82-3090

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/13/2019

Event Type  Injury  

Event Description

The siphon guard device was placed backwards as there was no arrow to describe the direction of flow on the device.For the application we were using, it connected easily and there was no clear warning about flow direction.This was ultimately caught and corrected.

• Brand Name: CODMAN SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8398774
• MDR Text Key: 138104696
• Report Number: 8398774
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2019,01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 82-3090
• Device Catalogue Number: 82-3090
• Device Lot Number: 203979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention