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

Model Number	750180
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: a bivona mid-range aire-cuf adult tracheostomy tube was returned and visual inspection identified that the inflation valve was positioned deep into the airway balloon.The opening of the inflation balloon was magnified, revealing no tears or cuts that would prevent the inflation valve from seating properly into the balloon.In addition, no manufacturing defects were identified with the inflation balloon.Cuff inflation and air leak tests were performed on the device.Air could be removed from the device without any problems and the cuffs remained inflated without issues.Cuffs were also inflated and deflated eight additional times to ensure the inflation valve remained in place.Based on the investigation and testing, it was determined the device was manufactured to specification and no leak was confirmed.However, it was noted that user interface may have caused the condition with the valve, that likely a twisting motion or excessive force was applied to the inflation valve when attaching the syringe, which would cause the valve to advance down into the balloon.
Event or Problem Description
Information was received that the white valve from the pilot balloon of a smiths medical bivona mid-range aire-cuf adult tracheostomy tube "went in and never came back out.Therefore the patient leaked".Subsequently, an emergent tracheostomy tube change out was performed.No adverse patient effects were reported.

• Brand Name: BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF, PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8391663
• Report Number: 3012307300-2019-01167
• Device Sequence Number: 1921593
• Product Code: JOH
• UDI-Device Identifier: 15021312006421
• UDI-Public: 15021312006421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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 Model Number: 750180
• Device Catalogue Number: 750180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/05/2019
• 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