MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	5.0MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes adult aire-cuf trachs are defective.No adverse patient events reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Visual and functional testing were performed.Two samples were received in used conditions, without their original packaging and with their certificate of decontamination.The technician performed cuff symmetry test to the unit according to procedures.When the cuffs were inflated with 15 cubic centimeters cc of air, the cuffs inflated completely around the tube, but asymmetrical was seen.When the cuffs were measured using the rules of the percentage for the symmetry with the sample 1: 35.71% and sample 2: 37.93%.These results were over 33.3%, 0.333 1/3:2/3 that was the minimum acceptable for air cuff.Based on the test, the units were within specifications.The sample were tested on leak test.The test was performed under water procedure.No leaks were detected during testing.The reported issue was not confirmed.The root cause could not be determinate since the samples successfully passed leak and cuff symmetry test.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11890455
• Report Number: 3012307300-2021-05141
• Device Sequence Number: 3686218
• 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): 04/01/2023

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: 5.0MM
• 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: 03/14/2023
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 04/01/2023
• 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