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

Catalog Number ST18JN60NSZ165N

Device Problem Inflation Problem (1310)

Patient Problem Increased Respiratory Rate (2486)

Event Date 10/09/2019

Event Type  Injury  

Event 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.

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
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9329290
• MDR Text Key: 166593872
• Report Number: 3012307300-2019-06318
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517169744
• UDI-Public: 15019517169744
• Combination Product (y/n): N
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: ST18JN60NSZ165N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention