MAUDE Adverse Event Report: ICU MEDICAL ASD, INC. BIVONA HYPTERFLEX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	67HA80
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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 reportable information becomes available.
Event or Problem Description
It was reported that there was a cuff leak on the tracheostomy tubes.This issue was solved by replacing with a new bivona (b)(6), with different lot number.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H4 - device mfg date: correction d3 - mfg establishment name, h3 and h6.Codes: updated.Device evaluation: received for investigation two (2) used product samples.No visible defects were noted.Both devices were leak tested and leaks were observed in both products in the same area of the cuff confirming the complaint.During manufacturing custom tracheostomy devices are leak tested twice prior to being sent to the customer.The observed defect cannot be attributed to the manufacturing process and was potentially caused due to improper device handling outside of icu medical control.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA HYPTERFLEX
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20140162
• Report Number: 1824231-2024-00078
• Device Sequence Number: 12616705
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: (01)15021312013818(17)270926(10)4329110
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 67HA80
• Device Lot Number: 4329110
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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