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

Model Number 67PFSS40

Device Problems Leak/Splash (1354); Tidal Volume Fluctuations (1634)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Narrative from staff: ventilator alarming due to large leak/high inspiratory tidal volume.Trach cuff found to have only 1.5cc volume,.5cc added.Soft trach ties adjusted and tightened.Scheduled respiratory treatments given without issue.Ventilation appears to be back to baseline.

• 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: 12967448
• MDR Text Key: 281981029
• Report Number: 12967448
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2021

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: 67PFSS40
• Device Catalogue Number: 67PFSS40
• Device Lot Number: 4015533
• 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: 11/22/2021
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 420 DA
• Patient Sex: Male
• Patient Weight: 8 KG