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

Catalog Number	60A180
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the inner cannula was sticking to a smiths medical tracheostomy tube, making it difficult to move.A tracheostomy tube change out occured as a result.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Device underwent functional testing to verify the cannula adheres to the tracheostomy tube.The reported customer complaint has not been confirmed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a problem source 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 north; minneapolis MN 55442
• MDR Report Key: 8363963
• Report Number: 3012307300-2019-00897
• Device Sequence Number: 1994988
• Product Code: JOH
• UDI-Device Identifier: 15021312005578
• UDI-Public: 15021312005578
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K913859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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
• Operator of Device: No Information
• Device Catalogue Number: 60A180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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: Life Threatening; Required Intervention