MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA® ADULT MID-RANGE AIRE-CUF® TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	755180
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical portex® bivona® adult mid-range aire-cuf® tracheostomy tube leaked after two to three weeks of use.It was also reported that the patient has been connected to a ventilator for the past several months.A 10cc syringe was used to fill the cuff.However, a trach change was required and the patient was reported to have experienced "more discomfort." there were no further reported adverse effects.
Additional Manufacturer Narrative
One bivona® adult mid-range aire-cuf® tracheostomy tube was returned for analysis.The samples was inflated per leak test with no issues.Based on the evidence there is no fault found as the complaint was not confirmed.

• Brand Name: PORTEX® BIVONA® ADULT MID-RANGE AIRE-CUF® 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: 8001980
• Report Number: 3012307300-2018-01476
• Device Sequence Number: 428035
• Product Code: JOH
• UDI-Device Identifier: 15021312006483
• UDI-Public: 15021312006483
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 09/21/2022
• Device Catalogue Number: 755180
• Device Lot Number: 3499829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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: Life Threatening; Required Intervention