MAUDE Adverse Event Report: BECTON DICKINSON VITAL SIGNS; ANESTHESIA CIRCUIT

Model Number GNSFXXGX

Device Problems Fluid/Blood Leak (1250); Torn Material (3024)

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

Event Type  malfunction  

Event Description

Tear in tubing causing leak in anesthesia machine circuit.

• Brand Name: VITAL SIGNS
• Type of Device: ANESTHESIA CIRCUIT
• Manufacturer (Section D): BECTON DICKINSON; franklin lakes NJ 07417
• MDR Report Key: 6116395
• MDR Text Key: 60644468
• Report Number: MW5066198
• Device Sequence Number: 1
• Product Code: CAZ
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GNSFXXGX
• Device Lot Number: 0000973057
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1