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

Catalog Number	60A170
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the iso-15 connector is too small.Speaking valves are not fixed when an inner cannula is used.There was no patient involvement and no human harm.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Investigation summary: two used units and photos were received for evaluation.The provided pictures by the complainant were reviewed.Visual inspection of the returned devices by the unaided eye and under normal plant lighting did not reveal any anomalies with the connectors.The returned inner canula was determined to be the correct size to be used with the returned trachs: 7.0 mm id.Using an iso taper gage, the taper of the connector on both devices was checked.They were deemed to be compliant with iso 5356-1.The returned speaking valve when placed on the connector without the returned inner canula fits appropriately on the connector.A request was made to r&d to review the manufacturing drawing.Confirmation was received from r&d that the drawing office reviewed the connector and determined that it is designed to meet the requirements of the standard.Connectors that are at the middle or top of tolerance will push the inner cannula ring pull beyond the top end of the iso specification.Most connectors have some space to accommodate such events, but if a component is used that is at the bottom end of the iso female connector specification, then it will clash with the inner cannula ring pull.Based on the r&d engineer and verification engineering manager review of the complaint; it is believed that the root cause is that the 15mm connector may be towards the middle of the specification and that the accessory may be mid to bottom of the iso specification, which resulted in the components interfering and not allowing a secure connection.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA TRACHEOSTOMY TUBES, ADULT UNCUFFED
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19563743
• Report Number: 1824231-2024-00056
• Device Sequence Number: 17699376
• Product Code: JOH
• UDI-Device Identifier: 15021312005561
• UDI-Public: (01)15021312005561(17)280719(10)4400725
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60A170
• Device Lot Number: 4400725
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown