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

Catalog Number	670190
Medical Device Problem Codes	Fluid/Blood Leak (1250); Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k) - k083641 smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that the patient experienced a leak in the cuff of a portex® bivona® adult tts¿ tracheostomy tube.After noticing the leak, the patient went into the hospital and had the tracheostomy tube replaced.The staff in the hospital filled the cuff, and observed water slowly leaking out of a small hole.The cuff had been checked prior to be inserted in the patient, however it was it noted that because the hole was small, no leakage was observed during that check.No injury was reported.
Additional Manufacturer Narrative
One portex® bivona® adult tts¿ tracheostomy tube we returned for analysis.Visual inspection of the device did not identify any defects, although it appeared used and discolored.The device was leak tested.No leaks were detected.Investigation of the device could not confirm the fault occurred.

• 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: 6651178
• Report Number: 3012307300-2017-01259
• Device Sequence Number: 11050295
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K944178
• 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): 12/08/2017

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: 670190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1