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

Model Number	ST20BN45NGF967N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex bivona tts fixed tracheostomy tube was hard to inflate.It was reported that the water was difficult to be pushed through.It was thought that the trach tube was missing a piece or was faulty.There were no reported adverse patient effects.
Additional Manufacturer Narrative
A thorough investigation could not be performed due to no complaint product sample being returned.However, with the photos taken by the complainant a brief analysis can be written regarding this incident.Based on the part number provided, (b)(6), it can be confirmed that this device was manufactured in southington.In reference to photos 1 and 3 attached to (b)(4), which pictures the pilot balloon, it appears that the inflation valve is present and has been pushed passed its proper seating position.While reviewing details of the incident, it is documented that the trach had been used on multiple occasions before this issue had occurred.Although the root cause could not be defined with confidence, it seems highly likely this happened while the syringe was attached to the pilot balloon and excessive force was applied.This can be corrected while the syringe is still attached by pulling back a little on the valve to make sure it is in the correct position.Smiths medical truly values the input of our customers and is committed to resolving quality related issues.Without evaluating the actual sample we cannot assess or confirm whether a quality related issue has resulted in the user?s reported difficulties.Complaint information will continue to be monitored.Product is accepted based on meeting specification requirements.If any nonconformance's are found in process, the product is isolated, non-conformed and immediate corrective action is taken.Inspections and tests are conducted by trained operators through 100% screening inspection before shipment.
Event or Problem Description
No product was returned.Summary from pictures and engineer attached.

• 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: 10395724
• Report Number: 3012307300-2020-08081
• Device Sequence Number: 2671199
• Product Code: JOH
• UDI-Device Identifier: 15019517219807
• UDI-Public: 15019517219807
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: Health Professional
• Device Expiration Date: 02/12/2025
• Device Model Number: ST20BN45NGF967N
• Device Catalogue Number: ST20BN45NGF967N
• Device Lot Number: SS026931
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1