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

Model Number	FT22CN60NSF994N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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.
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.No harm to the patient.
Additional Manufacturer Narrative
Corrected data: updated description, to represent no patient injury.
Event or Problem Description
Additional information indicated that a medical intervention was needed to remove the broken device from patient.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• 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: 14239592
• Report Number: 3012307300-2022-07060
• Device Sequence Number: 4302572
• Product Code: JOH
• UDI-Device Identifier: 15019517296990
• UDI-Public: 15019517296990
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FT22CN60NSF994N
• Device Catalogue Number: FT22CN60NSF994N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 04/28/2022; 01/31/2023
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/27/2022; 03/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown