MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, CUFFED, SPIRAL-FLEX 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN044799
Medical Device Problem Codes	Material Separation (1562); Medical Gas Supply Problem (2985)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the inner layer of the tube separated from the other part of the tube during the procedure.This inner layer got bigger and created a small bump that obstructed the tube.Clinical consequences: increase of ventilation pressure, difficult to properly ventilate the patient.Patient desaturated, extubation and manual ventilation done to resolve the desaturation.Patient is reported as fine post the procedure.
Event or Problem Description
It was reported that: the inner layer of the tube separated from the other part of the tube during the procedure.This inner layer got bigger and created a small bump that obstructed the tube.Clinical consequences: increase of ventilation pressure, difficult to properly ventilate the patient.Patient desaturated, extubation and manual ventilation done to resolve the desaturation.Patient is reported as fine post the procedure.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "disconnects from inner tube wall - wire" was confirmed based upon the investigation of the sample received.The customer returned one unit 5-12614 et tube, cuffed, spiral-flex 7.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the tube was cut at two locations: at approximately the 21cm and 23cm marks.The tube was kinked as the inner wall was collapsed inside the tube between the 18-23cm marks.It could not be determined if the tube was kinked before the tube was cut, but it was likely that the tube was kinked to some degree.A device history record review was performed on the spiral-flex et tube with no evidence to suggest a manufacturing related cause.The damage observed on the et tube is consistent with damage that can be caused by pinching the tube with high force.It could not be determined what caused the tube to kink, but it could have been caused by the positioning of the patient and/or the patient biting the tube.A bite block was not returned with the tube.Based on the location and the type of damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ET TUBE, CUFFED, SPIRAL-FLEX 7.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; colonia panamericana, chihuahua; tecate 21478 ; MX 21478
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18424243
• Report Number: 9680794-2024-00002
• Device Sequence Number: 7743633
• Product Code: BTR
• UDI-Device Identifier: 04026704397402
• UDI-Public: 04026704397402
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K844296
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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 Expiration Date: 05/20/2024
• Device Model Number: IPN044799
• Device Catalogue Number: 5-12614
• Device Lot Number: 73E1900571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2019
• 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; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown