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

Model Number 60P055

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2021

Event Type  Injury  

Event Description

It was reported that during use, the customer found it difficult to insert the product into the patient.The customer also noticed that the patient had trouble discharging sputum.The customer checked the device and found a protrusion in it.The device was exchanged to resolve the issue with no patient injury.No patient injury.

Manufacturer Narrative

Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests.Dhr review was not completed as there was no lot number available.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 12725661
• MDR Text Key: 279262173
• Report Number: 3012307300-2021-10495
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312005783
• UDI-Public: 15021312005783
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60P055
• Device Catalogue Number: 60P055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention