MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN926930
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 during use on a patient, the balloon does not hold inflation.As a result, a new ett was used however, the same issue occurred.A third ett was used and was successful.No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdr #3003898360-2023-01047.
Event or Problem Description
It was reported that during use on a patient, the balloon does not hold inflation.As a result, a new ett was used however, the same issue occurred.A third ett was used and was successful.No patient harm or injury.The patient status is reported as "fine".See associated mdr #3003898360-2023-01047.
Additional Manufacturer Narrative
Qn#(b)(4).Additional information received on 11 july 2023 after the initial mdr was sent states that "the tube was tested with 10 ccs of air.I saw it inflate and squeezed the balloon briefly before removing the air for intubation" and that the ett was in use for "about 10-15 minutes the patient didn't desaturate.When the patient was intubated and the balloon was inflated, the respiratory therapist could not get a reliable pressure reading with a device she was using.The small balloon at the beginning of the et tube was deflated which was another sign the balloon wasn't working well.Lastly, a ventilator was attached indicating an air leak prompting us to remove the tube entirely".It also states that "there was no overt or obvious signs of defect was noticed after the tube was removed and tested again".Other remarks: n/a; corrected data: n/a.

• Brand Name: ET TUBE, HVT, 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17298288
• Report Number: 3003898360-2023-01031
• Device Sequence Number: 7145982
• Product Code: BTR
• UDI-Device Identifier: 14026704759252
• UDI-Public: 14026704759252
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 09/23/2026
• Device Model Number: IPN926930
• Device Catalogue Number: 5-10315
• Device Lot Number: 73J2100708
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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