MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® UNIPERC® TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/080CZ
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff on the portex® uniperc® tracheostomy tube was difficult to inflate.No serious injury was reported in connection with this incident.
Additional Manufacturer Narrative
One used tracheostomy tube was returned for analysis.Visual analysis found that the tube appeared to be in good condition.Functional testing included an inflation test.The device cuff was inflated and after a 12 hour period the cuff was found to be significantly deflated.Then the sample was submerged in water and the tracheostomy tube cuff was inflated using a syringe filled with air.Air was observed to be leaking from inflation lumen which was found to be cut.The device history record was reviewed and no manufacturing or testing issues were found.Based on the evidence, the complaint was confirmed.The root cause was likely the cut of the inflation lumen.

• Brand Name: PORTEX® UNIPERC® TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7504722
• Report Number: 3012307300-2018-01496
• Device Sequence Number: 19220069
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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 Expiration Date: 04/18/2022
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 3404439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1