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

Model Number 75HA70

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2020

Event Type  malfunction  

Event Description

It was reported that tracheostomy tube become displaced.The device moved to a higher position than the 9 centimetres where it was originally set.The lock was supposed to hold the tube at the level set, however the tube was moving upwards when the patient moved their head.The trach was replaced with a fixed length silicone tube.The patient was admitted to the hospital in order to have this done.No adverse patient effects were reported.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY TUBE AND CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10834369
• MDR Text Key: 216084705
• Report Number: 3012307300-2020-11424
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2023
• Device Model Number: 75HA70
• Device Catalogue Number: 75HA70
• Device Lot Number: 3233576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 19 YR
• Patient Weight: 17