MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA ADULT TTS TRACHEOSTOMY TUBES; JOH

Catalog Number	XT16JS65NSC006S
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the bivona tracheostomy tube over inflated on one side of the balloon.No reported adverse effects.

• Brand Name: PORTEX BIVONA ADULT TTS TRACHEOSTOMY TUBES
• Common Device Name: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7770052
• Report Number: 3012307300-2018-03071
• Device Sequence Number: 2061451
• Product Code: JOH
• UDI-Device Identifier: 15019517075915
• UDI-Public: 15019517075915
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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): 08/09/2018

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: XT16JS65NSC006S
• 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: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1