MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES CUSTOM; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT17LN35NGE059N
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device serial number/lot number is unknown, no product information has been provided to date.No lot or serial number was provided; therefore, device history record review could not be performed.No product sample was received; therefore, visual and functional testing could not be performed.The valve is not unique to the customized 3.5 mm devices.It is used on all standard and customized devices.There have been no changes to the valve or to pilot balloon, which holds the valve.There have been no other complaints alleging the valves are falling out.No corrective actions are planned at this time.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It has been reported that the valve used to inflate the cuff was falling out of the tracheostomy.It was discovered prior to patient use and while it was being used via the patient.It resulted in a tracheostomy tube change as the cuff could not be inflated.It was advised that this has happened to approx.Seven tracheostomies and this also occurred while the patient was an inpatient in hospital.A further two tracheostomies were provided to the family on discharge home as he only had one that was institute.Then a further one was taken to the family ten days later which totals up to seven tracheostomies from (b)(6) 2022 till (b)(6) 2022.No patient injury reported.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; lichfield; minneapolis, MN 55442
• MDR Report Key: 15485082
• Report Number: 3012307300-2022-20252
• Device Sequence Number: 7848130
• Product Code: JOH
• UDI-Device Identifier: 15019517135053
• UDI-Public: 15019517135053
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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 Model Number: FT17LN35NGE059N
• Device Catalogue Number: FT17LN35NGE059N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 9 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White