MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® PORTEX® ULTRAPERC® SINGLE DILATOR TECHNIQUE KITS WITH OR WITHOUT BLUE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/541/080CZ
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cannula of a smiths medical tracheostomy kit presented a spontaneous breakdown of the extension cuff.A replacement device was then used.

• Brand Name: PORTEX® PORTEX® ULTRAPERC® SINGLE DILATOR TECHNIQUE KITS WITH OR WITHOUT BLUE
• 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: 8519695
• Report Number: 3012307300-2019-01523
• Device Sequence Number: 1515401
• Product Code: BTO
• UDI-Device Identifier: 15019315106606
• UDI-Public: 15019315106606
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 08/16/2023
• Device Catalogue Number: 100/541/080CZ
• Device Lot Number: 3661045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention