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

Model Number	67NFPS35
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).A device history review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample and two images were received for evaluation.Visual and functional testing were performed.During visual inspection, it was observed that the device was in used conditions, without the original packaging and with its certificate of safe handling.During functional testing, the complaint was not confirmed.When the sample was inflated with air, the cuff only inflated one side.According to the ifu (instruction for use) the pilot balloon was manipulated and the cuff inflated.After the whole cuff inflated, it was deflated and inflated four times.Every time the cuff inflated completely and symmetrically.The root cause of the reported issue could not be determined.No actions were taken.
Event or Problem Description
It was reported that the cuff was not inflating fully during pre-test.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: 16316461
• Report Number: 3012307300-2023-00994
• Device Sequence Number: 8657612
• Product Code: JOH
• UDI-Device Identifier: 10351688518798
• UDI-Public: 10351688518798
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 67NFPS35
• Device Catalogue Number: 67NFPS35
• Device Lot Number: 4066292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• 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: 01/31/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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