MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA CUSTOM FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	ST18JN60NSZ165N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Increased Respiratory Rate (2486)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that immediately following placement of a smiths medical portex bivona custom flextend¿ tts¿ tracheostomy tube, the cuff was observed to not be inflating properly.The patient was reported to not be getting the appropriate tidal volume needed and their respiratory rate was 30-35 respirations a minute.Subsequently, a trach tube change out was performed.The patient recovered with no further adverse patient effects.
Additional Manufacturer Narrative
One custom 6.0mm id fixed tracheostomy tube with swivel connector and tts cuff was returned for analysis.The inflation valve was found to be pushed inside the balloon upon visual inspection.The inflation valve was reseated to its normal position, a syringe was used to inflate the cuff; cuff remained inflated.The air was then removed, and the cuff was leak tested.Based on the evidence, there was no fault found as the complaint was not confirmed.

• Brand Name: PORTEX BIVONA CUSTOM FLEXTEND¿ TTS¿ 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: 9329290
• Report Number: 3012307300-2019-06318
• Device Sequence Number: 19457483
• Product Code: JOH
• UDI-Device Identifier: 15019517169744
• UDI-Public: 15019517169744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2024
• Device Catalogue Number: ST18JN60NSZ165N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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