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

Catalog Number	65SP045
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a cuff to a smiths medical portex® bivona® aire-cuf® tracheostomy tube was noted to deflate easily 12 days following placement.It was reported that 1.2 mls of air was instilled into the cuff the trach and decreased to 0.5 mls in two hours.There was no reported adverse effects.

• Brand Name: PORTEX® BIVONA® MID-RANGE AIRE-CUF® ADULT TRACHEOSTOMY TUBES
• 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: 7523477
• Report Number: 3012307300-2018-01603
• Device Sequence Number: 1224176
• Product Code: JOH
• UDI-Device Identifier: 15021312000313
• UDI-Public: 15021312000313
• Combination Product (Y/N): N
• PMA/510(K) Number: K944178
• 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): 05/17/2018

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: 65SP045
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1