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

Catalog Number	100/597/090
Medical Device Problem Code	Leak/Splash (1354)
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 uniperc tracheostomy tube cuff had a leak.No serious injury was reported in connection with this incident.
Additional Manufacturer Narrative
One portex® uniperc® tracheostomy tube was received for analysis in used condition.Under visual inspection it was noticed that on tube body there is a plastic wire which is not part of our product.During the manufacturing process, the devices are 100% tested for inflation, which involves inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure.The inflation test was repeated on the sample.After the 12 hour period the cuff was still fully inflated.Then the sample was submerged in water and the tracheostomy tube cuff was inflated using a syringe filled with air.No air leakage was observed.The device history record was not performed because no fault was found.

• Brand Name: 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: 7504716
• Report Number: 3012307300-2018-01490
• Device Sequence Number: 183993
• Product Code: BTO
• UDI-Device Identifier: 15019315060304
• UDI-Public: 15019315060304
• 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): 07/05/2018

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: 02/28/2018
• Device Catalogue Number: 100/597/090
• Device Lot Number: 2784512
• 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: 06/08/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1