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

Model Number	IPN048951
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that "the air leaked from the cuff before use on a patient.Therefore, a new unit was opened instead".No patient involvement reported.

• Brand Name: HUDSON ET TUBE,CUFFED ORAL,SPIRAL-FLEX 7.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12288089
• Report Number: 3003898360-2021-00652
• Device Sequence Number: 4672801
• Product Code: BTR
• UDI-Device Identifier: 14026704616999
• UDI-Public: 14026704616999
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 02/24/2025
• Device Model Number: IPN048951
• Device Catalogue Number: 5-12515
• Device Lot Number: 73B2000607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1