MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX UNIPERC PERCUTANOUS KIT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	100/597/080CZ
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign (b)(6).
Event or Problem Description
Information was received that a smiths medical portex uniperc percutaneous kit tracheostomy tube cuff leaked.No adverse patient effects were reported.

• Brand Name: PORTEX UNIPERC PERCUTANOUS KIT TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8181548
• Report Number: 3012307300-2018-08820
• Device Sequence Number: 16623203
• Product Code: JOH
• UDI-Device Identifier: 55019315107144
• UDI-Public: 55019315107144
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: 11/30/2020
• Device Catalogue Number: 100/597/080CZ
• Device Lot Number: 3379047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1