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

Model Number	67PFSS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit inflated but cuff did not.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
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The investigation notes that the product was in used conditions without original package.Visual inspection was performed at 12" under normal lighting to received unit, to detect any damage on the cuff, airline, or pilot balloon.No damage could be detected.The sample was tested on leak test - cuff was inflated successfully.No problems or issues were identified during this device history record review.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.

• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15717844
• Report Number: 3012307300-2022-26640
• Device Sequence Number: 20502010
• Product Code: JOH
• UDI-Device Identifier: 10351688518675
• UDI-Public: 10351688518675
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: Health Professional
• Device Expiration Date: 06/16/2026
• Device Model Number: 67PFSS30
• Device Catalogue Number: 67PFSS30
• Device Lot Number: 4159994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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 Sex: Unknown