MAUDE Adverse Event Report: ICU MEDICAL MANUFACTURING S.A. DE C.V. PORTEX ENDOTRACHEAL TUBE, SILICONIZED; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/111/025
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither sample nor pictures were received for the analysis of this complaint.No device history record was reviewed since lot number was not provided.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the complaint will be reopened for further investigation.
Event or Problem Description
It was reported that the stylet got twisted inside the tube and would not allow the stylet to be pulled out.Reporter stated that this happened twice: once the stylet just got stuck, the second one twisted inside of the stylet.Reporter stated the product was not reprocessed or re-sterilized prior to use.The event occurred when attempting intubation on an infant in the nursery.

• Brand Name: PORTEX ENDOTRACHEAL TUBE, SILICONIZED
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23009128
• Report Number: 3012307300-2025-10469
• Device Sequence Number: 9989506
• Product Code: BTR
• UDI-Device Identifier: 15019315018848
• UDI-Public: (01)15019315018848
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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: 100/111/025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/09/2025
• 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
• Patient Sex: Unknown