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

Model Number	67SN035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.
Event or Problem Description
It was reported that during a bedside exchange by the ent provider the balloon would not expand for the trach.The reported event was resolved by placing a different trach.There was no patient injury reported.
Additional Manufacturer Narrative
Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Samples received: two used samples were received without their original packaging, with their certificate of safe handling and their obturator.Visual inspection results: no discrepancies were found during the inspection.Functional test: the 2 samples received were inflated with air using 5 ml syringe, after that the cuffs were gently manipulated.Results: the cuffs were inflated without abnormalities.It was demonstrated that the cuffs were symmetrical, and no leak was detected.The complaint is not confirmed.No corrective actions was required since the complaint was not confirmed.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review., corrected data: e4: correction: customer reported to fda: no information.

• Brand Name: BIVONA NEO/PED TTS 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13928045
• Report Number: 3012307300-2022-05369
• Device Sequence Number: 1713453
• Product Code: JOH
• UDI-Device Identifier: 15021312000252
• UDI-Public: 15021312000252
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 09/05/2026
• Device Model Number: 67SN035
• Device Catalogue Number: 67SN035
• Device Lot Number: 4185413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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