MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670170
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was impossible for the caregivers to deflate the balloon, the patient "feels unable to breathe".The caregivers had to change the canula.No patient injury or clinical affects was reported.
Additional Manufacturer Narrative
Other text: d4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.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
One device was received for investigation.The device was visually inspected and functionally tested.In the inflation test of the balloon and we detected some difficult to inflate the balloon.The reported complaint is confirmed.This issue could be caused by an obstruction and/or occlusion in the inflation line, this prevents the air flow injected through the inflation line from being inadequate, causing difficulty in inflating the balloon.No corrective actions are required.A review of the device history records could not be completed as no lot number was provided by the customer.
Additional Manufacturer Narrative
Updated h11.One device was received for investigation.The returned sample was visually inspected at 12" to 16" and normal conditions of illumination according to the inspection procedure md01-003 rev 003.Per visual inspection, it was not detected any issue in the component that cause difficulty in inflating the balloon.According to visual aid av-10006853 "leak testing and cuff symmetry visual aid" rev.103, a leak test was performed to confirm that the returned sample present an inflation issue; it was detected that it was difficult to inflate the cuff with the support of a syringe; the pilot balloon was overinflated and the cuff presented difficulties to inflate and unable to deflate.This issue could be caused by an obstruction and/or occlusion in the inflation line, this prevents the air flow injected through the inflation line from being inadequate, causing difficulty in inflating the balloon.No corrective actions are required.A review of the device history records could not be completed as no lot number was provided by the customer.

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneaplis, MN 55442 ; 2247062300
• MDR Report Key: 18155385
• Report Number: 3012307300-2023-10573
• Device Sequence Number: 17789145
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: 15021312006056
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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 Catalogue Number: 670170
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/16/2023
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/21/2024; 03/27/2025
• 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 Age: 32 YR
• Patient Sex: Male
• Patient Weight: 34 KG