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

Model Number	67NFP35
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer facility phone number: (b)(6).
Event or Problem Description
Information was received indicating that a smiths medical trach was noted to only inflate three fourths of the way around leaving an incomplete seal.On further inspection, the cuffs were able to be inflated but this required a significant amount of manipulation to achieve this.The customer is worried about sterility of the cuffs if this needs to be done prior to insertion.There were no reported adverse events.
Additional Manufacturer Narrative
Other, other text: device evaluation: three device samples were returned for analysis in used condition without their original packaging.An air cuff symmetry test was performed and the investigation found that when the samples were inflated with air, the cuff inflated completely.When measuring the cuffs, the percentage for the symmetry was for sample 1: 50%, sample 2: 50%, sample 3: 44.4%.These results are over 33.3% that is the minimum acceptable.Based on the test the units were within specification.Based on the investigation, the complaint allegation 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
• MDR Report Key: 11046686
• Report Number: 3012307300-2020-12614
• Device Sequence Number: 11021295
• Product Code: JOH
• UDI-Device Identifier: 10351688518750
• UDI-Public: 10351688518750
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: Health Professional
• Device Model Number: 67NFP35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 05/01/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1