MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SP055
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical portex bivona tts (tight-to-shaft) tracheostomy tube cuff leaked immediately upon use.Subsequently, a tracheostomy (trach) change out was required.No adverse patient effects were reported.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.It was noted that device was shipped to customers on (b)(6), 2010, which dates this device at a minimum of eight years old at the time the complaint was initiated.All bivona tracheostomy devices have a shelf life of five years.Device was leak tested, and a leak was noted at the inflation line / neck flange junction.There appeared to be adequate adhesive applied to attach the airway line to the neck flange, and the inflation line appeared to have been torn resulting in the cuff to deflate.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 TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE
• 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: 8145356
• Report Number: 3012307300-2018-08651
• Device Sequence Number: 19399772
• Product Code: JOH
• UDI-Device Identifier: 15021312000757
• UDI-Public: 15021312000757
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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 Model Number: 67SP055
• Device Catalogue Number: 67SP055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 12/09/2018
• Supplement Report FDA Received Date: 03/29/2019
• 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: Required Intervention
• Patient Age: 27 YR