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	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A visual inspection of the product involved in the complaint was performed on two pictures received by the customer of product code 5-10405 (et tube, uncuffed, 2.5).From the pictures it was confirmed the defect reported by the customer "occlusion - kinked".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.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 "we had a defective et tube on one of our nicu babies.The et tube near the stylet (tip) has an internal deformity and suction catheters do not pass through the tube.We had to pull the tube out of the baby and use another tube".No injury or harm reported.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
• MDR Report Key: 12448215
• Report Number: 3003898360-2021-00778
• Device Sequence Number: 4060743
• Product Code: BTR
• UDI-Device Identifier: 14026704616814
• UDI-Public: 14026704616814
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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
• Operator of Device: No Information
• Device Expiration Date: 09/07/2025
• Device Model Number: IPN048902
• Device Catalogue Number: 5-10405
• Device Lot Number: 73J2000261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUCTION CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention