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

Catalog Number	5-12615
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during intubation, the anesthesiologist, at the time of inflating the balloon of the tube, identifies the presence of leakage, pressure is not maintained, the tube is changed.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20190732
• Report Number: 3003898360-2024-01151
• Device Sequence Number: 8249637
• Product Code: BTR
• UDI-Device Identifier: 04026704397419
• UDI-Public: (01)04026704397419(11)240122(17)290120(10)73A2400495(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5-12615
• Device Lot Number: 73A2400495
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2024
• 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: NOT REPORTED
• Patient Sex: Unknown