MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONIA; TRACHEOSTOMY

Model Number	5.0 MM
Medical Device Problem Codes	Inflation Problem (1310); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine tracheostomy change, parents were unable to deflate the fome cuf to remove the tube in situ.Problem solving was attempted but not successful.Parents took kid to ed where ent was able to remove the tube with steady pressure.Upon closer inspection of the faulty tube, it appeared that there was a communication between the embedded cuff inflation line and the inside of the distal shaft.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: investigation completed on a smiths medical fluid tracheostomy|silicone - bivona tubes custom was investigated with leak testing.The test revealed the cuff would not inflate or deflate.While air was being inserted.This was believed to be caused by in sufficient adhesive inserted inside the embedded airway line.When air was injected it instead escaped and the end of the shaft due to lack of adhesive.End connector was removed to view the embedded airway line.Photos were attached in file.This is malfunction of bonding.

• Brand Name: BIVONIA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11566738
• Report Number: 3012307300-2021-02507
• Device Sequence Number: 11799963
• Product Code: JOH
• UDI-Device Identifier: 15019517143980
• UDI-Public: 15019517143980
• 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: consumer,distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: Lay User/Patient
• Device Expiration Date: 01/18/2026
• Device Model Number: 5.0 MM
• Device Catalogue Number: ZZ21AN50NSF025N
• Device Lot Number: GA014516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1