MAUDE Adverse Event Report: INTERSURGICAL INC. BREATHING CIRCUIT

Model Number B0062000

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Manufacturer Narrative

During usage the exhalation vent may become covered or blocked when assembling hme or filter on the connector.In placing the hme or filter on the connector the tubing may be pushed up the connector.This force would overcome the tubing/ connector interference fit and allowed the tube to move.This could potentially cover the exhalation port.There were no patient issues reported during this evaluation.The instructions for use provide safe and effective directions.The instructions for use state "when assembling any connectors use a push and twist action to ensure a secure fit".It also states during set up "secure all connections, pressurize device and check for leakage and blockage prior to use".There were no patient issues reported during this usage.

Event Description

During usage the exhalation vent may become covered or blocked when assembling hme or filter on the connector.

• Brand Name: BREATHING CIRCUIT
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): INTERSURGICAL INC.; 6757 kinne street; east syracuse NY 13057
• Manufacturer Contact: michael wojnovich ; 6757 kinne street; syracuse, NY 13057 ; 3154512900
• MDR Report Key: 7409751
• MDR Text Key: 105275901
• Report Number: 1319447-2018-00002
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: B0062000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: No
• 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