MAUDE Adverse Event Report: ICU MEDICAL, INC TRACHEAL TUBE CLEAR MURPHY EYESOFT SEAL CUFF; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/199/080J
Medical Device Problem Codes	Inflation Problem (1310); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
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 when attempting to inflate the cuff, the pilot balloon became full, making it difficult to get air into the cuff.The event occurred before patient use during priming at the facility.There was no reported patient harm/adverse event.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc d9: date returned to mfg; 4/17/2025.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.Functional testing and visual inspection performed during analysis.The customer reported complaint could be confirmed.During cuff deflation, the cuff did not deflate while the pilot balloon was completely deflated.The probable cause is due to excess solvent applied at the inflation line-trach junction during manufacturing.

• Brand Name: TRACHEAL TUBE CLEAR MURPHY EYESOFT SEAL CUFF
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21769678
• Report Number: 3012307300-2025-03762
• Device Sequence Number: 8200365
• Product Code: BTR
• UDI-Device Identifier: 15019315022326
• UDI-Public: (01)15019315022326(17)290703(10)6013476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 100/199/080J
• Device Lot Number: 6013476
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• 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