MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA TRACHEOSTOMY TUBE; CONNECTOR, AIRWAY (EXTENSION)

Device Problems Detachment of Device or Device Component (2907); Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

When attempting to disconnect the patient from the ventilator they were met with extreme resistance.When finally able to remove it from the vent circuit the swivel adaptor that was connected to the trach came off with it and was stuck in the vent circuit.This caused the clinical staff to not have the ability to ventilate the patient through the trach tube.A code event occurred and the patient received cpr.Fortunately the patient did survive the event.Fda safety report id # (b)(4).

• Brand Name: PORTEX BIVONA TRACHEOSTOMY TUBE
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14160198
• MDR Text Key: 289768700
• Report Number: MW5109149
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1