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

Catalog Number	670185
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See mfr: 3012307300-2017-01768 (same patient).(b)(6).
Event or Problem Description
It was reported that the cuff of a portex® bivona® adult tts¿ tracheostomy tube was "pierced".The patient had returned home from the hospital with the tracheostomy tube.Seven days later, the cuff was pierced.The tracheostomy tube was replaced.No injury was reported.
Additional Manufacturer Narrative
One used portex® bivona® adult tts¿ tracheostomy tube was returned for investigation.A visual inspection of the device showed no issues.Functional testing revealed a cut in the cuff about 1 ½ mm in size.Based on the information provided by the reporter and the investigation the defect was not a manufacturing issue.Due to the length of time between the installation and the occurrence of the defect and the appearance (i.E., jagged edges) of the cut, it appears there may be something in the trachea that is causing the cut in the cuff.

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ 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: 6788402
• Report Number: 3012307300-2017-01771
• Device Sequence Number: 16536240
• Product Code: JOH
• UDI-Device Identifier: 15021312006087
• UDI-Public: 15021312006087
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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: No Information
• Device Catalogue Number: 670185
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR