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 Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 attached 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".
Event or Problem Description
The customer 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.Then we found the same deformity in the tubes of lot '73j2000261.".An mdr was filed for the event that occurred during use on the patient: mdr# 3003898360-2021-00778.This mdr is filed for the et tubes that were found by the customer prior to use on a patient.An exact quantity could not be defined by the customer.Mdr#.
Additional Manufacturer Narrative
(b)(4).The customer returned eight samples from unit 5-10405 et tube, uncuffed, 2.5 for investigation.One sample was returned out of its original packaging and seven representative samples were also returned unopened in their original packaging.The returned et tubes were visually examined with and without magnification.Visual examination revealed that all eight tubes were kinked on the proximal end of the murphy eye.A non-conformance has been opened at the manufacturing site to further investigate this issue.Corrected data: section b.5 - event description corrected to prior to use on patient.Section h.6.- health effect clinical code corrected to 4582.Section h.6.- health effect impact code corrected to 2645.

• 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: 12448118
• Report Number: 3003898360-2021-00789
• Device Sequence Number: 11777369
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/07/2025
• Device Model Number: IPN048902
• Device Catalogue Number: 5-10405
• Device Lot Number: 73J2000261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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
• Patient Sex: Unknown