MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX ENDOTRACHEAL TUBES POLAR; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/136/065
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: no information has been provided to date.Month and year; valid.H3: investigation including root cause analysis is in progress.A supplemental mdr will be filled 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 no problem during the pre-use check, but after anesthesia introduction and intubation, a leak was confirmed.There was patient involved/no adverse event reported.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: received one (1) used product sample.Per visual inspection, as received a black marker outlining an anomaly on the tracheal tube was observed.In attempts to replicate clinical use the cuff was inflated using an icu medical provided syringe.The cuff was observed to inflate but quicky deflated.In attempt to identify the location of the leak, red dye was pushed through the inflation line.Fluid was observed to leak from the anomaly previously noted.In attempts to better visualize the anomaly, it was cut out.A piece of the tracheal tube was observed to be carved out at the inflation line lumen of the tracheal tube.The complaint of leakage can be confirmed due to the damage observed.The probable cause is unknown.A device history record review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23025268
• Report Number: 3012307300-2025-10539
• Device Sequence Number: 15831292
• Product Code: BTR
• UDI-Device Identifier: 15019315021305
• UDI-Public: (01)15019315021305(17)280901(10)4424554
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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 Catalogue Number: 100/136/065
• Device Lot Number: 4424554
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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