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

Model Number	FT19AN60NSF077N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were seven devices that were returned.During the visual inspection, there were no abnormalities found.Using a standard syringe, 12cc's of air was inserted into the airway lines of all the devices.There were no issues identified with cuff inflation; all cuffs inflated.A standard ruler was used to measure cuff symmetry on all the devices.Measuring from the center of the shaft to the outside of the cuff, five measured 13mm on one side and 15mm on the opposite side.Device number six measured 11mm and 15mm and device number seven measured 11mm and 13mm.All devices met the manufacturing specification of 1/3:2/3 for cuff symmetry.The instruction for use, states under set up that if the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft.The reported problem could not be confirmed.No corrective actions are planned at this time.The manufacture regularly analyzes complaint data and trends and will take further actions accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that uneven inflation and spec found in multiple cuffs.No patient injury was reported.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15436843
• Report Number: 3012307300-2022-19390
• Device Sequence Number: 12161337
• Product Code: JOH
• UDI-Device Identifier: 15019517178364
• UDI-Public: 15019517178364
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: FT19AN60NSF077N
• Device Catalogue Number: FT19AN60NSF077N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown