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

Model Number	FT22BN35NGE920N
Medical Device Problem Codes	Break (1069); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer was using the tracheostomy on her one year old daughter, a patient with a critical airway that cannot be bagged or intubated from above.The trach had fallen out, but she was able to put it in right away.At that time it was noticed that one of the phalanges had broken off rendering the trach useless.The trach was a brand-new trach and received in october.Two different trachs were chosen for emergency replacement, however those cuffs were found damaged at the time of placement, also rendering those trachs useless.Fourth tube was placed successfully.Patient remains stable.
Additional Manufacturer Narrative
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
H10: 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 reported cuff deflation; 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.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA CUSTOM TRACHEOSTOMY TUBE
• 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: 15908862
• Report Number: 3012307300-2022-27736
• Device Sequence Number: 5762204
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: Lay User/Patient
• Device Model Number: FT22BN35NGE920N
• Device Catalogue Number: FT22BN35NGE920N
• Device Lot Number: ST014673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 03/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR
• Patient Sex: Unknown