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	67HA70
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.Device evaluation in progress.
Event or Problem Description
It was reported that the bivona® adult tts¿ adjustable neck flange hyperflex¿ tracheostomy tube was in patient use for one week when it was observed that the cuff was broken.The reported device was replaced.The event was observed spontaneously by hospital personnel during the initial use of the device.According to the report, the cuff patency was tested prior to patient use and the cuff was filled with sterile water.No adverse effect to patient was reported.
Additional Manufacturer Narrative
One bivona® adult tts¿ adjustable neck flange hyperflex¿ tracheostomy tube was returned for investigation.A review of the device master record was conducted and it was found to be complete.Visual inspection of the returned device detected a large cut/puncture in the device cuff.The observed cut/puncture appeared to have been caused by a blunt point exerting pressure on one concentrated area of the cuff while it was inflated.According to the initial report, the device had been in patient use for one week prior to the reported event.Investigation was unable to definitively determine a root cause for the observed cut/puncture; however, no evidence was found to suggest a manufacturing defect.

• 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: 6461865
• Report Number: 3012307300-2017-00810
• Device Sequence Number: 476495
• Product Code: JOH
• UDI-Device Identifier: 15021312013801
• UDI-Public: 15021312013801
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: Health Professional
• Device Catalogue Number: 67HA70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1