MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TTS CUFFED PEDIATRIC WITH STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Model Number	67PFSS40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: foreign : (b)(6).
Event or Problem Description
Information was received that during use of a smiths medical bivona tts cuffed pediatric with straight neck flange tracheostomy tube the patient could not breathe after cuff inflation, tried twice.Subsequently, a trach tube change out was performed.No further adverse patient effects were reported.
Additional Manufacturer Narrative
One tracheostomy tube was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Sample then underwent functional testing, inflating cuff with 5cc of air.The cuff was noted to be inflating asymmetrically.Cuff was then manipulated and was able to be inflated as a result.The whole cuff was inflated and deflated four additional times, and each time it was noted to be inflating completely.Then the air cuff symmetry test was performed, and the percentage of symmetry for the cuff was 39.47 percent.Being that this is higher than the 33.3 percent minimum required, the unit was determined to be within specification.The reported customer complaint has not been confirmed.

• Brand Name: BIVONA TTS CUFFED PEDIATRIC WITH STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE
• 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: 8681471
• Report Number: 3012307300-2019-03446
• Device Sequence Number: 2292782
• Product Code: JOH
• UDI-Device Identifier: 15021312000726
• UDI-Public: 15021312000726
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: No Information
• Device Expiration Date: 04/03/2023
• Device Model Number: 67PFSS40
• Device Catalogue Number: 67PFSS40
• Device Lot Number: 3620219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/09/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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: Required Intervention