MAUDE Adverse Event Report: BIVONA FLEXTEND CUFFED TRACHEOSTOMY TUBES 4.0 PED; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problems Break (1069); Disconnection (1171)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

Previous tracheostomy tube breakage.Care provider walked into a room due to patient desaturation, found tracheostomy out of patient's neck.Upon inspection, it was found that the flange loop on trach broke allowing trach ties to become disconnected.Patient was then able to pull trach out causing desaturations and bradycardia due to loss of airway.A new, emergency trach was inserted and patient recovered.(b)(6).

• Brand Name: BIVONA FLEXTEND CUFFED TRACHEOSTOMY TUBES 4.0 PED
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• MDR Report Key: 16947748
• MDR Text Key: 315456371
• Report Number: MW5117601
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other