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

Catalog Number	100/897/070CZ1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a tracheostomy procedure after placing a portex® uniperc® adjustable flange tracheostomy tube, the cuff gets empty.No reported patient injury.
Additional Manufacturer Narrative
Additional information was received indicating that following placement of the portex® uniperc® adjustable flange tracheostomy tube, the cuff became empty.Subsequently the trach was required to be changed out.There were no reported adverse effects.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE 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: 7712544
• Report Number: 3012307300-2018-02801
• Device Sequence Number: 789939
• Product Code: BTO
• UDI-Device Identifier: 15019315107191
• UDI-Public: 15019315107191
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• 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): 09/04/2018

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: Health Professional
• Device Catalogue Number: 100/897/070CZ1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1