MAUDE Adverse Event Report: ICU MEDICAL CZECH REPUBLIC A. S PORTEX BLUE LINE ULTRA SUCTIONAID TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/870/090
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
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 reportable information becomes available.
Event or Problem Description
It was reported that during patient use, the suction aid port of the tracheostomy tube had split or cracked.It was also noted that the cuff failed due to a hole in the pilot balloon.The tube was replaced without issue, and no patient harm or adverse event was reported.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: received one (1) used blue line ultra suctionaid trach tube.As received, a small hairline crack was observed on the suction valve when attached to a syringe.When inflated and submerged, a leak was observed in the pilot balloon.No other physical damage or other anomalies observed.To replicate clinical use, an icu medical provided syringe was attached to both the pilot balloon valve and the suction valve.A crack was observed on the suction valve.Also, a leak was observed on the pilot balloon when submerged in water.The complaint that there was split in suction aid port and also noted that the cuff had failed due to a leak or hole in the pilot balloon can be confirmed.The probable cause of the split in the suction port is due to applying excessive force when connecting the syringe or suction device.Probable cause of the hole in the pilot balloon is unknown.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID TRACH TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23883919
• Report Number: 3012307300-2025-13738
• Device Sequence Number: 9650964
• Product Code: BTO
• UDI-Device Identifier: 15019315104886
• UDI-Public: (01)15019315104886(17)290125(10)4436024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/24/2026

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: 100/870/090
• Device Lot Number: 4436024
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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