MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. TRACHEAL TUBE CLEAR MURPHY EYESOFT SEAL CUFF; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/199/065J
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "pilot balloon deflates during patient use".This occurred during patient use, no patient harm/adverse event reported.
Additional Manufacturer Narrative
No device was received for investigation.Therefore, we are unable to determine the reported complaint.If we receive the device, we will reopen the investigation for further evaluations.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Additional Manufacturer Narrative
D9.Date returned to mfg: 23-jan-2025.H6.Investigation codes: updated investigation summary: received one (1) used.List #100/199/065j, tracheal tube for evaluation.As received, there were no damages or anomalies observed.In attempts to replicate clinical use, the cuff was fully inflated with air by an icu medical provided syringe.During the inflation process, the air could not be retained by the cuff.The cuff was then submerged in a water bath.A leak was observed at the junction of the inlet connection and the blue balloon.The complaint of the pilot balloon deflating can be confirmed.The probable cause is due to a channel being present from insufficient solvent application at the junction.

• Brand Name: TRACHEAL TUBE CLEAR MURPHY EYESOFT SEAL CUFF
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21118159
• Report Number: 9617604-2025-00025
• Device Sequence Number: 12631024
• Product Code: BTR
• UDI-Device Identifier: 15019315022319
• UDI-Public: (01)15019315022319(17)280228(10)4367786
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: 100/199/065J
• Device Lot Number: 4367786
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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