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

Model Number	67NFPS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical trach did not inflate.There were no reported adverse events.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter (b)(4).Additional information is provided in h3, h6, and h10 a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.One (1) sample was received in used conditions, without original packaging and with its certificate of safe handling.A leak test was performed to see if there was any functional problem.When the sample was inflated with air, the cuff only inflated one side.According to the instructions for use (ifu), the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically; based on analysis, the complaint is not confirmed.Root cause could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11046441
• Report Number: 3012307300-2020-12615
• Device Sequence Number: 1033929
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: 10351688518781
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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: 03/21/2024
• Device Model Number: 67NFPS30
• Device Lot Number: 3767440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown