MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® CUFFED FLEX D.I.C® TRACHEOSTOMY TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	503070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex® cuffed flex d.I.C® tracheostomy tube was not holding fluid.It was reported that the fluid leaks out.There were no reported adverse effects.

• Brand Name: PORTEX® CUFFED FLEX D.I.C® TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7874450
• Report Number: 3012307300-2018-03960
• Device Sequence Number: 2488388
• Product Code: BTR
• UDI-Device Identifier: 10351688009265
• UDI-Public: 10351688009265
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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: 503070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1