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

Catalog Number	5-12615
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "the patient had difficulty breathing.Before undergoing tracheostomy, the head nurse inserted an tracheostomy catheter into the patient.However, the patient experienced poor ventilation and airway obstruction.The nurse immediately replaced the catheter for the patient".Per the customer, no further information is available.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the patient had difficulty breathing.Before undergoing tracheostomy, the head nurse inserted an tracheostomy catheter into the patient.However, the patient experienced poor ventilation and airway obstruction.The nurse immediately replaced the catheter for the patient".Per the customer, no further information is available.If additional information is received, the complaint file will be updated.
Event or Problem Description
It was reported that "the patient had difficulty breathing.Before undergoing tracheostomy, the head nurse inserted an tracheostomy catheter into the patient.However, the patient experienced poor ventilation and airway obstruction.The nurse immediately replaced the catheter for the patient".Per the customer, no further information is available.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # udi related data quality updates only.

• Brand Name: SHERIDAN 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18401551
• Report Number: 3003898360-2023-01642
• Device Sequence Number: 3967595
• Product Code: BTR
• UDI-Device Identifier: 04026704397419
• UDI-Public: (01)04026704397419(11)230315(17)280314(10)73C2300522(21)
• 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,Followup,Followup
• Report Date (Section B): 12/04/2023

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 Catalogue Number: 5-12615
• Device Lot Number: 73C2300522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/29/2024; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/30/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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
• Patient Sex: Unknown