MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, CUFFED, SPIRAL-FLEX 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12615
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that (b)(6) 2024, during the process of tracheal intubation for general anesthesia, the patient's airway pressure su ddenly increased, and after checking, it was found that the reinforced trachea was bent, so it was reset and fixed, and it was observed that the airway pressure returned to normal.During sputum suctioning, the lumen of the endotracheal tube was found to be deformed, and it was difficult to place the sputum tube.After extubation, it was observed that the wire in the endotracheal tube was displaced, and there was no supporting ability of the unprotected portion of the wire, which did not bring adverse consequences to the patient, and the anesthesia process was smooth.There was no reported patient harm from the incident.".

• Brand Name: ET TUBE, CUFFED, SPIRAL-FLEX 7.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20558313
• Report Number: 3003898360-2024-01373
• Device Sequence Number: 3114539
• Product Code: BTR
• UDI-Device Identifier: 04026704397419
• UDI-Public: (01)04026704397419(11)231030(17)281028(10)73K2300910(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 5-12615
• Device Lot Number: 73K2300910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Patient Sex: Unknown