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

Catalog Number	100/890/090CZ
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that fissures were observed on the inner cannula of a tracheostomy tube at the moment of cleaning.The inner cannula had been split along the entire outer curve.Customer had to change the inner cannula.No patient details were provided.

• Brand Name: PORTEX® UNIPERC® TRACHEOSTOMY TUBE INNER CANNULAE
• 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: 7558058
• Report Number: 3012307300-2018-02038
• Device Sequence Number: 16772320
• Product Code: BTO
• UDI-Device Identifier: 15019315107184
• UDI-Public: 15019315107184
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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 Catalogue Number: 100/890/090CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1