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

Catalog Number	67HA80
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that the cuff of this tracheostomy tube leaked while in use with a patient; it would not hold water.It was noted that this was a ventilator-dependent patient and the tracheostomy tube had to be changed out.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
One (b)(4) tracheostomy tube was returned for evaluation of the cuff.Upon visual inspection of the cuff, it was noted that there are tiny scratches throughout the entire cuff.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The product was leak tested with air, but was unable to inflate.Wall thickness of the cuff was then measured, and it passed wall thickness specification.The customer's complaint was 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® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿ 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: 7616426
• Report Number: 3012307300-2018-02440
• Device Sequence Number: 14008696
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: No Information
• Device Expiration Date: 05/05/2022
• Device Catalogue Number: 67HA80
• Device Lot Number: 3379593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention