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

Model Number	67HA60
Medical Device Problem Codes	Break (1069); Deflation Problem (1149)
Health Effect - Clinical Code	Hypoxia (1918)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cuff of the tracheostomy tube broke while in use with the patient.The patient experienced respiratory distress and was manually ventilated.The event occurred after 25 days of use.
Additional Manufacturer Narrative
Date of event and operator of device is unknown.No information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Problem and evaluation codes: updated h10 device evaluation: one device was returned for investigation.Upon visual inspection wear on the cuff was noted.Functional testing was performed and a leak at the top of the device was found, confirming the customers complaint.Abrasion marks were visible 14 mm above the distal tip on the top of the shaft.The abraded area was 4 mm long and 3 mm wide and it was located below and to the left (i.E., patient side) of the "2" along the gradient marking on the shaft.These marks are likely due to scrubbing action with a sharp implement.The leak emitted from one of the abraded marks.The instruction for use states under section 2 indications for use that the device is not intended for long-term use and is only for temporary use and should be replaced right away when the correct flange length is determined.Based on details in the complaint description, the device is being used longer than what is recommended by the instructions for use.A review of the device history record (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA SILICONE TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16342236
• Report Number: 3012307300-2023-01106
• Device Sequence Number: 12474091
• Product Code: JOH
• UDI-Device Identifier: 15021312013795
• UDI-Public: 15021312013795
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 67HA60
• Device Catalogue Number: 67HA60
• Device Lot Number: 4251781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown