MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	ST16LN50NGF151S
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a patient with a smiths medical portex® bivona® adult tts¿ tracheostomy tube makes a whistling noise with breathing.A backup tracheostomy (trach) was reported to be on hand.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One tracheostomy returned for evaluation.The device was reviewed and it was found to meet all of the dimensional requirements.The product was visually inspected and found to have no abnormalities, as well as leak tested.It has passed all functional testing.The reported customer complaint was not confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES
• 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: 8020717
• Report Number: 3012307300-2018-01938
• Device Sequence Number: 13751791
• Product Code: JOH
• UDI-Device Identifier: 15019517090529
• UDI-Public: 15019517090529
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: No Information
• Device Expiration Date: 08/16/2023
• Device Catalogue Number: ST16LN50NGF151S
• Device Lot Number: DS018253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1