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

Catalog Number	750170
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that the balloon to a smiths medical portex® bivona® aire-cuf® adult tracheostomy tube would deflate.The balloon was required to be inflated every two hours with 1-2mls of air.It was reported that the patient was under ventilated for 22 hours.The cannula was reported to be changed every 15 days.There were no reported adverse effects.
Additional Manufacturer Narrative
One 7.0 air cuff device was returned in used condition.Using a leak test procedure, 20cc of air was applied to the device.There were no leaks detected while the entire device was manipulated.The cuff was then filled with 20cc of air and allowed to sit for 2 hours with a slight loss of volume as expected with silicone air cuff devices.The complaint stated that the balloon often deflated which is typical of air cuff devices.The direction for use states: use either minimal leak or minimal occlusive volume techniques to establish the cuff and to ensure correct inflation at regular intervals.All air device cuffs are 100% leak tested prior to packaging.This investigation did not confirm the complaint and did not reveal any intrinsic manufacturing defects with the returned device.Since no manufacturing defect was confirmed there are no corrective actions planned at this time.Smiths medical regularly analyzes complaint data and trends and will take further actions accordingly.

• 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 n; minneapolis, MN 55442
• MDR Report Key: 7808917
• Report Number: 3012307300-2018-03460
• Device Sequence Number: 2076916
• Product Code: JOH
• UDI-Device Identifier: 15021312006414
• UDI-Public: 15021312006414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 750170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR