MAUDE Adverse Event Report: ICU MEDICAL, INC PORTEX TRACHEAL TUBE MAXILLO FACIAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/133/065
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was checked for air leakage after insertion, and it was found that there was a air leak.Although there was no leakage during cuff check before insertion.The event occurred during patient use/dose, and there was no adverse event.
Additional Manufacturer Narrative
H3, h6: 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.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc.Device evaluation: one device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.The customer reported complaint was confirmed.There are micro tears on the cuff surface, all in the same general direction parallel to the trach.A leak was observed during functional testing.The probable cause is due to contact with patient teeth during intubation.

• Brand Name: PORTEX TRACHEAL TUBE MAXILLO FACIAL
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC; ave calidad no. 4, parque; industrial internacional; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22026501
• Report Number: 3012307300-2025-05715
• Device Sequence Number: 7136229
• Product Code: BTR
• UDI-Device Identifier: 15019315020346
• UDI-Public: (01)15019315020346(17)290517(10)6010631
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100/133/065
• Device Catalogue Number: 100/133/065
• Device Lot Number: 6010631
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown