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

Model Number	65SN030
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that no anomaly was observed at the pre-use check of a smiths medical bivona tube neo/ped aire-cuf tracheostomy tube, however, during the its use, the customer noticed air pressure of the cuff was lowered sooner than usual.The user suspected that the cuff was damaged and they stopped using the product.There was no patient injury.
Additional Manufacturer Narrative
One tracheostomy tube was returned for evaluation.Visual inspection found it to be in good physical condition.Device underwent functional testing; unable to confirm the reported customer complaint.Unit was inflated and visually inspected for 10 seconds.No leakage was observed.B1, h1: corrected data; incident does not meet the definition of a serious injury, as device did not require medical or surgical intervention to preclude serious impairment of a body structure or function.This incident is a malfunction reportable incident.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10421262
• Report Number: 3012307300-2020-08275
• Device Sequence Number: 16891939
• Product Code: JOH
• UDI-Device Identifier: 15021312000030
• UDI-Public: 15021312000030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: No Information
• Device Expiration Date: 06/21/2023
• Device Model Number: 65SN030
• Device Catalogue Number: 65SN030
• Device Lot Number: 3659594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1