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

Catalog Number	5-12614
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the spiral coil keeps getting kinked." the patient desated below 95%.They were reported as fine after the in cident.
Additional Manufacturer Narrative
(b)(4).Section d.4.- corrected to 'unknown'.The full udi number is not available as complainant did not report a lot number.The customer returned one unit 5-12614 et tube, cuffed, spiral-flex 7.0 for investigation.The returned et tube was visually examined with and without magnification.Visual examination of the sample revealed that the tube was kinked throughout the length of the tube.The inner part of the tube was occluded due to the kink.It was evident that the returned sample would not pass a kink test based on the extent of the damage.No functional testing was performed on the returned sample.It was evident that the returned sample would not pass a kink test based on the extent of the damage observed.The customer did not provide a lot number; t herefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The ifu for this product states "if a reinforced tube is used orally, a bite block is recommended." the reported complaint of "tube kinked" was confirmed based upon the sample received.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.Based on the type of damage observed, unintentional user error caused or contributed to this event.Corrected data: (b)(4).
Event or Problem Description
It was reported that: "the spiral coil keeps getting kinked." the patient desated below 95%.They were reported as fine after the incident.

• 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; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19653682
• Report Number: 3003898360-2024-00777
• Device Sequence Number: 6632391
• Product Code: BTR
• UDI-Device Identifier: 04026704397402
• UDI-Public: 04026704397402
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: 5-12614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown