MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED FLEXTEND; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFSS50
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record (dhr) review.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection was performed at a distance of 12 to 16 inches and normal conditions of illumination in order to detect any damage on the cuff, airline or pilot balloon and there was no damage detected.During the functional testing the samples as filled with 5cc of air in order to see if there was any functional problem and when inflating the unit with air, it was seen that cuff inflated but a part was not uniformly.The cuff was manipulated and the whole cuff inflated.However, extremely force was needed to inflate the cuff.After the whole cuff inflated, it was observed that cuff had silicon excess on the cuff band and the cuff sees asymmetrical.The root cause was related to manufacturing.A corrective action plan has been implemented for this issue.
Event or Problem Description
It was reported that during a pre-insertion inflation check of the device it was discovered that the cuff was not inflating fully and evenly around circumference of trach tube.No patient injury was reported.

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND
• 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: 15591523
• Report Number: 3012307300-2022-23596
• Device Sequence Number: 19415182
• Product Code: JOH
• UDI-Device Identifier: 10351688518712
• UDI-Public: 10351688518712
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: 67PFSS50
• Device Catalogue Number: 67PFSS50
• Device Lot Number: 3757624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2019
• 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