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

Model Number	FT22BN35NGE920N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer has an additional custom trach that had broken.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
One used product was received for investigation as well as photographs of the product.The photos show a device with evidence of torn, damaged neck flange with flange eyelets attached to a velcro material and the device with evidence of the cuff airway piece slightly detached from the neck flange.Visual and functional testing was performed.The item was submerged in water to identify any holes in the cuff area or gaps in adhesive that may have led to the cuff deflation reported by the complainant; however no leakage was noted during evaluation despite the observed damage.Of note, the customer photos display use of velcro instead of the supplied twill tape to secure the neck flanges on the devices.It is not possible to determine how the device became damaged, however if the tube does come into contact with a sharp material, such as velcro, it is possible to cause a tear which can propagate further during use.Based on the device analysis, the complaint cannot be confirmed as a manufacturing nonconformance, but is highly probable to have been caused by a variation in user technique.A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16067642
• Report Number: 3012307300-2022-28236
• Device Sequence Number: 6294255
• Product Code: JOH
• UDI-Device Identifier: 15019517296372
• UDI-Public: 15019517296372
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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 Model Number: FT22BN35NGE920N
• Device Catalogue Number: FT22BN35NGE920N
• Device Lot Number: ST014673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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
• Patient Age: 1 YR
• Patient Sex: Unknown