MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. TRACHEAL TUBE IVORY NASAL SOFT SEAL CUFF; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/179/070
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2024
Type of Reportable Event	Serious Injury
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-conformance's during the manufacturing of the reported lot number.
Event or Problem Description
It was reported the patient's blood oxygen saturation dropped to 85%, and a large amount of light bloody fluid was sucked out of the mouth and pharynx.The doctor performed an emergency nasotracheal intubation.After the nasotracheal intubation was successfully inserted, when the balloon was fixed, it was found that the inflation end of the tracheal intubation balloon could not be inflated and was in an empty state.After evaluation, the nasotracheal intubation balloon may have quality problems such as leakage.To ensure the patient's normal ventilation, the nasotracheal intubation was replaced.When the nasotracheal intubation was removed, it was found that the balloon at the end of the tracheal intubation that closed the airway had been inflated to a large amount and was spherical, but the balloon was in an empty state.There was patient involvement, but no patient harm/adverse event reported.

• Brand Name: TRACHEAL TUBE IVORY NASAL SOFT SEAL CUFF
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21252729
• Report Number: 3012307300-2025-01234
• Device Sequence Number: 8056356
• Product Code: BTR
• UDI-Device Identifier: 15019315022128
• UDI-Public: (01)15019315022128(17)280614(10)4407765
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 01/28/2025

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 Catalogue Number: 100/179/070
• Device Lot Number: 4407765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown