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

Model Number	FT22BN60NSF961N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 custom part numbers for the retaining ring breaking.The little ring part broke in pieces which is incredibly dangerous for our patients.All i had to do was squeeze them a little and they broke.
Additional Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).No devices were returned for evaluation as part of this investigation.However, the complainant provided a video.In the video, it is very clear that the retaining ring has been damaged and is not serving its intended function.That said, it is unclear how or when this damage became present.Based on the correspondence from the complainant, it seems they are accustomed to smaller sized tubes where they were able to remove the swivel connector.In the particular tube that the customer is complaining about, the swivel connector is not intended to be removed.Based on this information, it is concluded that the damage to the retaining ring is highly likely to have been caused by a customer usage issue.Without receiving the actual sample for evaluation, it is not possible to make a more definitive conclusion.No corrections or corrective actions are deemed necessary at this time.No problems or issues were identified during this device history record review.Update: h6, h10.

• Brand Name: BIVONA CUSTOM TUBE
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14239406
• Report Number: 3012307300-2022-07062
• Device Sequence Number: 4887434
• Product Code: JOH
• UDI-Device Identifier: 15019517295009
• UDI-Public: 15019517295009
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: FT22BN60NSF961N
• Device Catalogue Number: FT22BN60NSF961N
• Was Device Available for Evaluation?: No
• 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: 03/31/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown