MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. BIVONA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problems Break (1069); Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2021

Event Type  malfunction  

Event Description

This rn was attempting to disconnect vent tubing from trach in order to change patient's shirt.Vent tubing difficult to disconnect from trach with wedge.When disconnected, it was noted that the plastic piece that goes around the silicone hub of the trach that connects to the vent, was broken off into the inside of the inline suction.Patient had no distress noted.Mds aware of broken piece.Trach changed out by rt and rn.

• Brand Name: BIVONA
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11378535
• MDR Text Key: 233496348
• Report Number: 11378535
• Device Sequence Number: 1
• Product Code: BTO
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 360 DA