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

Catalog Number	ZU25BN35NGE150N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that shortly after use/application of the cannula, the eyelet broke.The issue occurred immediately upon use, at the patient¿s home.The cannula was changed by a nurse.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.It was reported that it was confirmed the flange was torn at the eyelet.It was also noticed that the other eyelet had signs of tearing at the eyelet.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.A damaged eyelet can result in decannulation of the tracheostomy tube.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: DISP BIVONA TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23511331
• Report Number: 3012307300-2025-12248
• Device Sequence Number: 15941432
• Product Code: JOH
• UDI-Device Identifier: 10887709148458
• UDI-Public: (01)10887709148458
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: ZU25BN35NGE150N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/20/2026
• 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 Age: 21 YR
• Patient Sex: Unknown