MAUDE Adverse Event Report: ICU MEDICAL ASD, INC. BIVONA TUBES ADULT AIRE-CUF WITH TALK ATTACHMENT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	755190
Medical Device Problem Codes	Break (1069); Disconnection (1171); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that the inflation line is broken and disconnected.There was no reported patient involvement.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
D1 - brand name and d3 - mfr establishment name: correction.H6.Codes: updated.Device evaluation: no product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: BIVONA TUBES ADULT AIRE-CUF WITH TALK ATTACHMENT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24800704
• Report Number: 3012307300-2026-03387
• Device Sequence Number: 10678699
• Product Code: JOH
• UDI-Device Identifier: 15021312006490
• UDI-Public: (01)15021312006490
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 755190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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