MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048895
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Per dhr the et tube, hvt, 7.0 lot # 73l2101034 was manufactured on (b)(6)2021 a total of 21,000 pieces.Lot was released on 12/13/2021.Dhr investigation did not show issues related to complaint.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported via medwatch report.The report states that the "patient required intubation 3 times due to cuff balloon deflating after in tubation of 2 attempts.Endotracheal tube size 7.0.Balloon cuff of 7.5 ett stayed inflated throughout surgical case without incident.Patient's o2 sats, ventilator tidal volumes, and peak pressures maintained.No adverse effects noted to patient condition during above or pacu reported.Recommend removing ett 7.0 from service with replacement 7.0 ett made available for use and/or check cuff b alloon inflation twice before use of ett in circulation." associated mdr 3003898360-2022-00648.
Event or Problem Description
Reported via medwatch report.The report states that the "patient required intubation 3 times due to cuff balloon deflating after in tubation of 2 attempts.Endotracheal tube size 7.0.Balloon cuff of 7.5 ett stayed inflated throughout surgical case without incident.Patient's o2 sats, ventilator tidal volumes, and peak pressures maintained.No adverse effects noted to patient condition during above or pacu reported.Recommend removing ett 7.0 from service with replacement 7.0 ett made available for use and/or check cuff balloon inflation twice before use of ett in circulation." associated mdr 3003898360-2022-00648.
Additional Manufacturer Narrative
Qn # (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.

• Brand Name: ET TUBE, HVT, 7.0
• 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: 15725633
• Report Number: 3003898360-2022-00686
• Device Sequence Number: 11481205
• Product Code: BTR
• UDI-Device Identifier: 14026704616746
• UDI-Public: 14026704616746
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 06/28/2026
• Device Model Number: IPN048895
• Device Catalogue Number: 5-10314
• Device Lot Number: 73F2100926
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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 Age: 23 YR
• Patient Sex: Male
• Patient Race: Black Or African American