MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE CUFFED SPIRAL-FLEX 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048959
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the anesthesiologist intubates the patient, at the moment of wanting to inflate the balloon it no longer inflates, the anesthesiologist comments that it was possibly punctured.The anesthesiology assistant confirms that the balloon was in perfect condition before the procedure to intubate".There was no report of patient impact or consequence.Patient condition unknown at time of report.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer provided four photos but was unable to be confirm the failure mode reported as "inflation issue - unable to inflate".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.A verification of failure mode reported in the current manufacturing process was conducted as follows: 50 samples were taken from the current production; the samples were visually inspected, and issue reported "inflation issue - unable to inflate" 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.

• Brand Name: HUDSON ET TUBE CUFFED SPIRAL-FLEX 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14631912
• Report Number: 3003898360-2022-00199
• Device Sequence Number: 14926075
• Product Code: BTR
• UDI-Device Identifier: 14026704617071
• UDI-Public: 14026704617071
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 03/23/2025
• Device Model Number: IPN048959
• Device Catalogue Number: 5-12614
• Device Lot Number: 73C2000374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• 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
• Patient Sex: Unknown