MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, UNCUFFED, 2.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048902
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 125 samples were taken from the current production; the samples were visually inspected, and issue reported "occlusion - kinked" was not observed in the current manufacturing process.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "the customer contacted us stating that they have item # kc5-10405 et on hand that is defective.They stated that the tube was placed in the patient, the patient started decompensating, tried to pass a suction catheter through, would get stuck.Extubated patient and reintubated with new tube.They took the suction catheter to an old tube and noticed inside of the tube was narrowed, and the catheter would not pass through".Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4) the customer returned one unit 5-10405 et tube, uncuffed, 2.5 for investigation.A suction catheter was also returned.The returned et tube was visually examined with and without magnification.Visual examination revealed that the tube was kinked on the proximal end of the murphy eye.Functional inspection was performed to try and pass the suction catheter through the et tube.The suction catheter was unable to pass the section of the tube that was kinked, confirming the reported complaint.A non-conformance has been opened at the manufacturing site to further investigate this issue.
Event or Problem Description
It was reported "the customer contacted us stating that they have item # kc5-10405 et on hand that is defective.They stated that the tube was placed in the patient, the patient started decompensating, tried to pass a suction catheter through, would get stuck.Extubated patient and reintubated with new tube.They took the suction catheter to an old tube and noticed inside of the tube was narrowed, and the catheter would not pass through".Patient condition reported as "fine".

• Brand Name: HUDSON ET TUBE, UNCUFFED, 2.5
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12646544
• Report Number: 3003898360-2021-00933
• Device Sequence Number: 1713160
• Product Code: BTR
• UDI-Device Identifier: 14026704616814
• UDI-Public: 14026704616814
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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
• Device Expiration Date: 03/15/2022
• Device Model Number: IPN048902
• Device Catalogue Number: 5-10405
• Device Lot Number: 73C1700406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2017
• 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: SUCTION CATHETER.; SUCTION CATHETER.; SUCTION CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown