MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Lot Number 3783828

Device Problems Inflation Problem (1310); Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Report source: united kingdom.

Event Description

Information was received that a smiths medical bivona pediatric tracheostomy tube trach was not inflating and if it does inflate, it is asymmetrically.No adverse patient effects were reported.

Event Description

Information was received that incident did occur while in patient use.Patient's tracheostomy tube was changed and replaced with a fully working tracheostomy.As it was the cuff issue, the patient's airway was maintained.

• Brand Name: BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9927173
• MDR Text Key: 186523169
• Report Number: 3012307300-2020-02910
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Lot Number: 3783828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 YR