MAUDE Adverse Event Report: ICU MEDICAL, INC.. BIVONA FOME CUFF TRACHEOSTOMY TUBE W/ TALK ATTACHMENT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	855180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Lot number, expiration date, and h4.Manufacture date are unknown; no information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that after changing the trach tube, the end of the suction channel broke.It was washed twice after the procedure with perasafe (disinfectant).It has been used for 4 weeks between each wash.The event occurred while in use with patient, and there was no patient harm/adverse event reported.
Additional Manufacturer Narrative
D3 - mfg establishment name: corrected d9 - date returned to mfg: 9/11/2024 h3 and h6 codes - updated one used device was returned for investigation.The devices were visually inspected and found the unaided eye under normal plant lighting confirmed that a portion of the suction controller was missing.The customer reported complaint was confirmed but a root cause was unable to be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BIVONA FOME CUFF TRACHEOSTOMY TUBE W/ TALK ATTACHMENT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC..; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20010229
• Report Number: 1824231-2024-00075
• Device Sequence Number: 19919311
• Product Code: BTO
• UDI-Device Identifier: 15021312006919
• UDI-Public: (01)15021312006919
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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 Catalogue Number: 855180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 12/31/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown