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

Catalog Number	FT15HN50NSF102S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Potential lot number: ds000903.The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.
Event or Problem Description
It was reported that the "balloon/cuff" of a portex® bivona® custom tracheostomy tube was leaking two days after being placed.Cuff patency was not tested prior to use.Sterile water was used to fill the cuff.The tracheostomy tube was replaced.No injury was reported.
Additional Manufacturer Narrative
Upon receipt of the returned product sample, it was visually examined.One used custom tracheostomy tube was received.No visual anomalies were noted.Functional testing was performed, and a leak was detected near the junction of the airway line and neck flange.On magnification, it appeared that the adhesive was not bonded to the shaft in a small area.A review of the device history record found no discrepancies.Manufacturing records showed this lot passed both leak tests.While a definitive root cause could not be determined, there are four possible root causes for which the reported issue could be attributed: contamination on the shaft prevented the adhesive from fully bonding in the isolated area.The adhesive was not smoothed around the airway line and neck flange before it started to cure.The airway line was pulled causing the adhesive to lift from the shaft.A combination of 1, 2 or 3 occurred.

• 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: 6609196
• Report Number: 3012307300-2017-01152
• Device Sequence Number: 475696
• Product Code: JOH
• UDI-Device Identifier: 15019517013696
• UDI-Public: 15019517013696
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: Nurse
• Device Catalogue Number: FT15HN50NSF102S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 20