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

Model Number	5.0 MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes adult aire-cuff were reported to be "defective." no patient adverse events reported.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Samples received: two (2) samples were received from p/n 750150 l/n unknown.In used conditions, without their original packaging and with their certificate of decontamination.Functional testing results: when the cuffs were inflated with 15cc of air, the cuffs inflated completely around the tube, but they see asymmetrical.When the cuffs were measured using the rules (id:13.3051 due:06/2024) and (id:13.2820 due:10/21) the percentage for the symmetry was for sample 1: 35.71%.Anf for sample 2: 37.93%.These results are over 33.3% (0.333 (1/3:2/3)) that is the minimum acceptable for air cuff.Based on the test, the units are within specifications.Functional test: the sample was tested on leak test.The test was performed under water as per pwi-10007269 rev.100 symmetry and leak test method.Results: no leaks were detected.No root cause could be determinate since the samples successfully passed leak and cuff symmetry test.The cause of the reported problem could not be determined.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• 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: 11889850
• Report Number: 3012307300-2021-05124
• Device Sequence Number: 3686213
• Product Code: JOH
• UDI-Device Identifier: 15021312006391
• UDI-Public: 15021312006391
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: Other
• Device Model Number: 5.0 MM
• Device Catalogue Number: 750150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown