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

Model Number 67N035

Device Problems Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)

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

Event Date 07/07/2021

Event Type  malfunction  

Event Description

The patient's trach tube became dislodged during routine care.The patient had a 3.0 neo bivona tts flextend in place at the time.The spare trach tube was inserted without checking the integrity of the cuff because of the emergent circumstances.A large leak around the trach tube was noted immediately despite the cuff being inflated with 2.5cc sterile h20 (previous trach had 2cc in cuff with no leak).A new trach tube was opened, and the respiratory therapist instilled sterile h20 into the cuff to check cuff integrity and it would not inflate.The respiratory therapist opened another trach and cuff would not inflate on that one either.The ent physician was called to the bedside and he was able to inflate the cuff after massaging cuff with fingers and instilling cuff with 5cc sterile h20.The cuff was misshapen and took some manipulation to make it symmetrical.The physician informed the nicu team that this has been an issue with bivona tts trachs.The new trach tube was then was placed with 2cc sterile h20 and no leak.After investigating further, the respiratory therapist found a video from the manufacturer that suggested the cuff may not inflate properly due to the nature of the silicone cuff toughing the silicon tube and the environmental conditions during storage.The manufacturer suggests massaging the cuff with fingers to loosen cuff and inflating the cuff with air when checking cuff integrity.Bivona trach 3.0 neo cuffed lot # 4024941, bivona trach 3.0 neo cuffed lot # 3955773.Images of both packages are attached.

• Brand Name: BIVONA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 12301147
• MDR Text Key: 265856215
• Report Number: 12301147
• 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: 07/28/2021,07/26/2021

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 Operator: No Information
• Device Model Number: 67N035
• Device Catalogue Number: 67N035
• Device Lot Number: 3955773
• 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: 07/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA