MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® ADULT MID-RANGE AIRE-CUF® ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	750190
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Information was received that a patient with a smiths medical bivona® adult aire-cuf® tracheostomy tube was not receiving air.Subsequently, the tube was changed out and the patient was able to breathe normally.No further adverse effects were reported.
Additional Manufacturer Narrative
One device was returned for evaluation.Visual inspection of the device did not identify any defects.Leak testing was performed with air and did not identify any leaks.An in-house clinician evaluated that patient anatomy may have caused the device to be over-filled to lead to the reported issue.Based on the evidence, a root cause was unable to be confirmed.No fault was found with the device.

• Brand Name: BIVONA® ADULT MID-RANGE AIRE-CUF® ADJUSTABLE NECK FLANGE HYPERFLEX¿ TRACHEOSTOMY
• 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: 7251401
• Report Number: 3012307300-2018-00253
• Device Sequence Number: 949654
• Product Code: JOH
• UDI-Device Identifier: 15021312006438
• UDI-Public: 15021312006438
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: Physician
• Device Expiration Date: 04/18/2021
• Device Catalogue Number: 750190
• Device Lot Number: 3192195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 03/15/2018
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 90