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

Model Number	67PFPS45
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device cuff did not inflate.No patient involvement.
Additional Manufacturer Narrative
Other, other text: investigation completed on a smiths medical tracheostomy|silicone - bivona tubes neo/ped flextend plus two samples received from p/n 67pfps45 l/n 3965904 for testing.Samples filled with 5 cc of air and only one side inflated.According to the ifu (10018859-001 rev.100 -instruction for use ? bivona tts flextend tracheostomy), the pilot balloon was manipulated, and the cuffs inflated completely.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuffs inflated completely.The complaint is not confirmed.Manufacturing reviewed and no discrepancies were noted.Complaint was not confirmed.
Event or Problem Description
Investigation completed and summary in h 10.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11167248
• Report Number: 3012307300-2021-00391
• Device Sequence Number: 3718258
• Product Code: JOH
• UDI-Device Identifier: 10351688518552
• UDI-Public: 10351688518552
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 67PFPS45
• Device Catalogue Number: 67PFPS45
• Device Lot Number: 3952145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1