MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 67PFSS45

Device Problem Leak/Splash (1354)

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

Event Date 12/30/2021

Event Type  malfunction  

Event Description

Patient¿s pulmonetics alarming for low volumes.Patient¿s cuff checked, down 2 ml of water from earlier in shift when 2 ml had already been replaced.Presumed cuff leak.Trach changed and old trach discarded.No further volume alarms from vent.No decompensation of patient status or desaturations.

• Brand Name: BIVONA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 13860446
• MDR Text Key: 287673511
• Report Number: 13860446
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 67PFSS45
• Device Catalogue Number: 67PFSS45
• Device Lot Number: 3832002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1