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

Catalog Number	65SP035
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex® bivona® aire-cuf® tracheostomy tube air pressure lowered.Subsequently, a tracheostomy (trach) tube change out was performed with no reported adverse patient effects.
Additional Manufacturer Narrative
One tracheostomy was returned without the original packaging for evaluation.Upon visual inspection of the device, no damage was observed to the cuff.Device underwent functional testing by filling it with 5cc of air, and as a result, no air loss was noted.Likewise when the device was submerged under water.The reported customer complaint was not confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX® BIVONA® AIRE-CUF® TRACHEOSTOMY TUBE
• 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: 8219917
• Report Number: 3012307300-2019-00092
• Device Sequence Number: 197507
• Product Code: JOH
• UDI-Device Identifier: 15021312000290
• UDI-Public: 15021312000290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: Health Professional
• Device Catalogue Number: 65SP035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/20/2019
• 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: Required Intervention