MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA 4.5 TTS HYPERFLEX FLEXTEND TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	XT16DS45NGF009S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related to mfr number: 3012307300-2019-04989 (same patient with two same device issues).
Event or Problem Description
Information was received that a smiths medical bivona 4.5 tts hyperflex flextend tracheostomy tube cuff was not inflating properly while in use with a patient.The reporter stated the patient's mother was in the process of a tracheostomy tube change, but was unable to complete the change out due to the event.It was also reported the patient had an old tube in the house that was able to be cleaned and used until a new tube arrived.No adverse patient effects were reported.
Additional Manufacturer Narrative
The results of the product evaluation (below) were not included in the initial supplemental report.This correction report now includes the investigation results of the returned product.Evaluation results: two customized 4.5 mm tracheostomy tubes (id hyperflex flextends with fixed connectors and tts cuffs) were returned for investigation because the devices were unable to inflate.Both devices were inflated using 7 cc's of air.Both devices were fully inflated and the investigator notes a small area stuck to the shaft causing the cuff to appear asymmetrical.The cuffs were then deflated and gently massaged, as specified in the instructions for use (ifu).The cuffs were inflated again with 7 cc's of air and the cuffs inflated properly.Both devices were leak tested in a water bath and no leaks were detected.

• Brand Name: BIVONA 4.5 TTS HYPERFLEX FLEXTEND TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9090327
• Report Number: 3012307300-2019-04990
• Device Sequence Number: 2297930
• Product Code: JOH
• UDI-Device Identifier: 15019517056471
• UDI-Public: 15019517056471
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/25/2019

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: Lay User/Patient
• Device Expiration Date: 03/15/2024
• Device Model Number: XT16DS45NGF009S
• Device Catalogue Number: XT16DS45NGF009S
• Device Lot Number: DS025187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 09/25/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/25/2019; 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1