MAUDE Adverse Event Report: RUSCH ET TUBE,CF,5.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048869
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Mdr report key/report number: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A verification of failure mode reported in the current manufacturing process was conducted as follows: 125 samples were taken from the current production, the samples were inspected according to qip, the revised characteristics comply with the requirement.Defect reported "leak - info not provided" was not observed in the current manufacturing process.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.
Event or Problem Description
Complaint from maude database: "ett (endotracheal tube) balloon not holding pressure without a red cap.The balloon on ett cuff was not staying inflated.Had to attach an additional red cap to keep air in balloon.Device still in the patient, will attempt to retrieve once tube is removed.There was no detectable harm in this event".

• Brand Name: RUSCH ET TUBE,CF,5.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• MDR Report Key: 12598273
• Report Number: 3003898360-2021-00893
• Device Sequence Number: 11768169
• Product Code: BTR
• UDI-Device Identifier: 14026704616487
• UDI-Public: 14026704616487
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/15/2021

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: No Information
• Device Expiration Date: 02/27/2025
• Device Model Number: IPN048869
• Device Catalogue Number: 5-10111
• Device Lot Number: 73B2000643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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