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

Catalog Number	5-12514
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the tracheal tube was bent and recovered, but the trachea created a narrowing that prevented recovery to complete v entilation." the user changed to a new set and the patient was reintubated.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unit 5-12514 et tube,cuffed oral,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 near the proximal end of the tube, between the bite block and the connector.A functional kink resistance test was performed on the returned et tube to determine resistance.The returned et tube was pre-conditioned in a water bath at 40 c for 6 hours.The et tube was strapped securely to a kink test fixture to create a radius of curvature of 40mm.A steel ball of a minimum 75% (5.25mm) of the designated size of the et tube is used to check the potency of the lumen.A ball bearing of 5.25mm was used for the kink test.The ball bearing could not pass freely through the tube due to the kink in the tube.The ifu for this product was reviewed as a part of this complaint investigation.The ifu 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.Visual examination of the returned sample revealed that the tube was kinked near the proximal end of the tube, between the bite block and the connector.The returned et tubes was functionally tested for kinking.A ball bearing could not freely pass through the tube.Resistance was met at the same location where the tubing was kinked.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.Based on the location and the type of damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported "the tracheal tube was bent and recovered, but the trachea created a narrowing that prevented recovery to complete v entilation." the user changed to a new set and the patient was reintubated.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: HUDSON ET TUBE,CUFFED ORAL,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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19825922
• Report Number: 3003898360-2024-00862
• Device Sequence Number: 12943670
• Product Code: BTR
• UDI-Device Identifier: 04026704397310
• UDI-Public: (01)04026704397310(11)231008(17)281007(10)73K2300117(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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
• Device Catalogue Number: 5-12514
• Device Lot Number: 73K2300117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown