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

Catalog Number	670175
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.A hole in the cuff was identified in each of the samples upon visual inspection.The root cause was identified to be the hole in the cuff.As a result, no action was taken due to the condition of the device.It was deemed to be beyond economical repair and will be scrapped.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that the first tracheostomy tube exhibited a leak on the next day after the placement.The second tracheostomy tube also exhibited a leak on the next day after placement.The issue was resolved after changing the tracheostomy tube to a bivona tube.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
The following fields, including the investigation summary, were updated with corrections: h6.Type of investigation: b01, b14 investigation summary: two samples were returned for evaluation in used condition, in a plastic bag.During visual inspection, a hole in the cuff was identified in each of the samples.The failure mode of ¿leaking¿ was confirmed.Capa-(b)(6) was opened on (b)(6) 2022, to address the root cause investigation for "cuffed products do not maintain inflation and leak".A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19745558
• Report Number: 1824231-2024-00060
• Device Sequence Number: 6491851
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: (01)15021312006063(17)270526(10)4293043
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: Health Professional
• Device Catalogue Number: 670175
• Device Lot Number: 4293043
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Race: Asian