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

Catalog Number	5-10116
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The report states, "ett cuff's not holding air.The issue was resolved by intubating the patient with a new ett.The patient current condition was reported as 'deceased'".Additional information received stated that the patient's underlying medical condition was reported as "critical" with past medical history including "aspiration pneumonia due to gastric secretions, basal ganglion hemorrhagic stroke with thalamic ischemic strokes".The cause of death is reported as "pulseless electrical activity, cardiac arrest".The patient was initially intubated on an inpatient medical/surgical floor.The defect was noticed after intubation and the patient experienced a "slight" desaturation to 91% sp02.The patient expired 5 hours after the event.The physician did not declare that the failure of the ett cuff to hold air caused or contributed to the patient's death.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "does not stay inflated - cuff" was confirmed based upon the sample received.The customer returned one unit 5-10116 et tube,cf,8.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appeared used as there was biological material present on the device.No defects or anomalies were observed.Functional inspection was performed on the returned device to test for proper inflation/deflation.A lab inventory syringe was filled with air and attached to the pilot balloon.Upon injection of air, the balloon cuff was unable to inflate.The et tube was submerged under water to test for leaks.Upon injection of air, the et tube leaked from two holes in the balloon cuff.The two holes were right next to each other.No other defects or anomalies were observed.A device history record review was performed, and no relevant findings were identified.The returned et tube was found to have two holes in the balloon cuff which prevented it from being able to stay inflated.A device history record review was performed with no evidence to suggest a manufacturing related cause.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
The report states, "ett cuff's not holding air.The issue was resolved by intubating the patient with a new ett.The patient current condition was reported as 'deceased'".Additional information received stated that the patient's underlying medical condition was reported as "critical" with past medical history including "aspiration pneumonia due to gastric secretions, basal ganglion hemorrhagic stroke with thalamic ischemic strokes".The cause of death is reported as "pulseless electrical activity, cardiac arrest".The patient was initially intubated on an inpatient medical/surgical floor.The defect was noticed after intubation and the patient experienced a "slight" desaturation to 91% sp02.The patient expired 5 hours after the event.The physician did not declare that the failure of the ett cuff to hold air caused or contributed to the patient's death.

• Brand Name: ET TUBE,CF,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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17698624
• Report Number: 3003898360-2023-01323
• Device Sequence Number: 20490919
• Product Code: BTR
• UDI-Device Identifier: 04026704396825
• UDI-Public: 04026704396825
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5-10116
• Device Lot Number: 73D2300594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 70 KG