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

Device Problem Inflation Problem (1310)

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

Event Date 11/29/2020

Event Type  malfunction  

Event Description

When preparing for a tracheostomy (trach) change, unable to inflate internal balloon.Outer balloon would fill but sterile water could not get into the internal balloon.Awaiting response from manufacturer.

• Brand Name: BIVONA
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITH MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11002364
• MDR Text Key: 221251389
• Report Number: 11002364
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2020
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 120 DA