MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, HVT, 8.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048895
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Low Oxygen Saturation (2477)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.P/n 5-10314 et tube, hvt, 7.0 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" (p/n 00003-12 lot # 3150288)and was conducted as follows: 200 samples were taken from the current production; the samples were visually inspected and issue reported "leak - info not provided" was not observed in the current manufacturing process.A device history record review could not be conducted since the lot number of the device was not provided.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "we had a patient that had an ett that needed changed out this morning due to a cuff leak again".It was further reported that the patient "encountered further respiratory distress, had to be extubated and reintubated.Patient did desaturate frequently [into the 70s] until tube was replaced".Patient condition unknown as it was reported "the patient was transferred from our unit".
Additional Manufacturer Narrative
(b)(4).The customer returned a size 8 et tube for investigation.Upon visual exam of the returned sample, it was determined that this was not a teleflex product.Multiple attempts were made to follow up on the returned sample; however, the customer has not responded.A second follow up report will be submitted if any pertinent information is received.
Event or Problem Description
It was reported "we had a patient that had an ett that needed changed out this morning due to a cuff leak again".It was further reported that the patient "encountered further respiratory distress, had to be extubated and reintubated.Patient did desaturate fequently [into the 70s] until tube was replaced".Patient condition unknown as it was reported "the patient was transferred from our unit".

• Brand Name: HUDSON ET TUBE, HVT, 8.0
• 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: 12844984
• Report Number: 3003898360-2021-01031
• Device Sequence Number: 17209884
• Product Code: BTR
• UDI-Device Identifier: 14026704616746
• UDI-Public: 14026704616746
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN048895
• Device Catalogue Number: 5-10316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VENTILATOR; VENTILATOR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown