MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA ¿ TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67P045
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the balloon to a smiths medical portex® bivona® tts¿ (tight-to-shaft) tracheostomy tube was found to be asymmetrical during pre-use check.The balloon was noted not to inflate on both sides of the tube.There were no reported adverse health effects.

• Brand Name: PORTEX BIVONA ¿ TTS¿ TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7759103
• Report Number: 3012307300-2018-03052
• Device Sequence Number: 1259118
• Product Code: JOH
• UDI-Device Identifier: 15021312006285
• UDI-Public: 15021312006285
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• 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): 08/07/2018

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: 02/02/2022
• Device Catalogue Number: 67P045
• Device Lot Number: 3363015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR