MAUDE Adverse Event Report: ICU MEDICAL, INC. BIVONA TRACHEOSTOMY TUBE, ADULT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	855180
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.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 the end of the suction channel broke and the expiration date is the same as the production date, both being old.There was patient involvement, but no patient harm.
Additional Manufacturer Narrative
D3 - mfg establishment name: corrected d9 - date returned to mfg: 9/11/2024 h3 and h6 codes - updated h4 - device mfg date: updated one used device was returned for investigation.The devices were visually inspected and revealed scratch marks on the swivel connector, the number three written on the underside of the neck flange, partial yellowing of the tip of the suction controller, stress marks (i.E., crazing) on the speaking valve, and two stress marks at the tip of the suction controller.The alleged complaint of a broken suction controller was not confirmed.The suction controller had evidence of cosmetic issues, but the component functioned.The labeling complaint was confirmed; the manufacturing and expiration dates listed on the variable label are the same.A new label software was implemented in december 2020, which eliminated the manual entry of the expiration date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20135195
• Report Number: 1824231-2024-00077
• Device Sequence Number: 15195803
• Product Code: JOH
• UDI-Device Identifier: 15021312006919
• UDI-Public: (01)15021312006919(17)251112(10)4051673
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• 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 Expiration Date: 11/12/2025
• Device Catalogue Number: 855180
• Device Lot Number: 4051673
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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