MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, CUFFED, SPIRAL-FLEX 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN926900
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor found tube kink when using on patient.Then changed new one, no impact on patient.Involved 1 pc.".
Additional Manufacturer Narrative
Qn# (b)(4).Per dhr the et tube, cuffed, spiral-flex 7.5 lot # 73k1800550 was manufactured on 10/16/2018.A total of (b)(4) pieces.Lot was released on 10/24/2018.Dhr investigation did not show issues related to complaint.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ET TUBE, CUFFED, SPIRAL-FLEX 7.5
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16733020
• Report Number: 3003898360-2023-00613
• Device Sequence Number: 12417935
• Product Code: BTR
• UDI-Device Identifier: 14026704759894
• UDI-Public: 14026704759894
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2023
• Device Model Number: IPN926900
• Device Catalogue Number: 5-12615
• Device Lot Number: 73K1800550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• 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: N/A.
• Patient Sex: Unknown