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

Model Number	67P055
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the devices cuff was inflating asymmetrically.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).No problems or issues were identified during the device history record review.A product sample was received for evaluation.Visual and functional testing were performed.When the sample was inflated with air, the cuff only inflated one side.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.When measuring the cuffs, the percentage for the symmetry was: 47%, these results are over 33.3% that is the minimum acceptable.Based on the test, the units are within spec.The complaint is not confirmed.No root cause could be determinate since the samples successfully passed cuff symmetry test.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: BIVONA TRACHEOSTOMY TUBES
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16475720
• Report Number: 3012307300-2023-01966
• Device Sequence Number: 7325530
• Product Code: JOH
• UDI-Device Identifier: 15021312006308
• UDI-Public: 15021312006308
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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: Lay User/Patient
• Device Model Number: 67P055
• Device Catalogue Number: 67P055
• Device Lot Number: 4116086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown