MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA ADULT TTS ADJUSTABLE NECK FLANGE HYPERFLEX TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67HA80
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex® bivona® adult tts¿ adjustable neck flange hyperflex¿ tracheostomy tube was reported to be broken and leaking 20 hours following placement.A trach tube change out was performed with no reported adverse effects.
Additional Manufacturer Narrative
One tracheostomy tube was returned for evaluation.Visual inpsection of the device found an issue with the airway line where it is attached to the connector hub.Device underwent functional testing, confirmed a leak at the airway line where it extends from the connector hub.The investigation did not determine a manufacturing defect with the returned device; problem source has been determined to be user interface.The instruction for use states under warnings to guard against product damage by avoiding contact with sharp edges.

• Brand Name: PORTEX BIVONA ADULT TTS ADJUSTABLE NECK FLANGE HYPERFLEX TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9673916
• Report Number: 3012307300-2020-00776
• Device Sequence Number: 14183681
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: 67HA80
• Device Catalogue Number: 67HA80
• Device Lot Number: 3800571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 06/04/2020
• 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 Age: 79 YR