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

Catalog Number	FT15LN90NSC861N
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Cyanosis (1798); Respiratory Distress (2045)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a portex® bivona® custom tracheostomy tube was narrow and stuff, and the patient experienced respiratory distress.The incident occurred shortly after placement.Air was used to fill the cuff.The patient could not move air and became "dusky" and blue, and was experiencing respiratory distress.The tracheostomy tube was replaced with the one that had just been removed.The patient consulted with their healthcare provider regarding the incident.No permanent injury was reported.
Additional Manufacturer Narrative
One portex® bivona® custom tracheostomy tube was returned for investigation.The tracheostomy tube was compared to a similar device and no abnormalities were observed.The device history record was reviewed and no related non-conformities were noted.Since a specific failure mode was not identified in the complaint report, a throughout inspection was performed for every item of the device that could potentially contribute to the reported issue (leak test, dimensional/curvature checks, visual inspection, etc.) and no non-conformities were found.It was noted that the reporter had filed a similar complaint in the past for the same patient, so it is possible there was a patient specific physiological issue that led to this complaint.Additionally, it was noted that the reporter stated they used air to inflate the cuff.Per the device instructions for use, sterile water should be used to inflate the tube.It was determined that the use of air likely would not have led to the specific issue.

• Brand Name: PORTEX® BIVONA® CUSTOM 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: 6612274
• Report Number: 3012307300-2017-01171
• Device Sequence Number: 16200994
• Product Code: JOH
• UDI-Device Identifier: 15019517035322
• UDI-Public: 15019517035322
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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: Nurse
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: FT15LN90NSC861N
• Device Lot Number: SS006771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 10/10/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 39 YR