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

Catalog Number	5-22216
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: " a balloon burst inside of a patient about 2 hours after being inserted.It was the 8.0 endotracheal tube.The staff said they heard a loud pop out of nowhere and it was from the balloon bursting".The patient was reintubated.There was no reported patient harm.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "a balloon burst inside of a patient about 2 hours after being inserted.It was the 8.0 endotracheal tube.The staff said they heard a loud pop out of nowhere and it was from the balloon bursting".The patient was reintubated.There was no reported patient harm.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unit 5-22216 et tube, preformed cuffed oral, 8.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that there was a large hole in the balloon cuff.The hole was indicative of the cuff being over-inflated which would cause the balloon cuff to burst.Functional inspection could not be performed based on the condition of the returned sample.A device history record review was performed and no relevant findings were identified.The ifu for this product states, "the tracheal tube cuff inflation system, including the valve, should be checked prior to intubation.If a malfunction is detected in any part of the inflation system, the tube should not be used." "care should be taken to avoid damaging the thin-walled cuffs during intubation.If cuff is damaged, the tube should not be used." the ifu also states, "deflate cuff prior to repositioning the tube.Movement of the tube with the cuff inflated could result in patient injury or in damage to the cuff, requiring a tube change.Verify the position of the tube after each repositioning." the reported complaint was confirmed based upon the sample received.The returned et tube was found to have a large hole in the balloon cuff.The hole was indicative of the cuff being over-inflated which would cause the balloon cuff to burst.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.

• Brand Name: ET TUBE, PREFORMED CUFFED ORAL, 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18977148
• Report Number: 3003898360-2024-00266
• Device Sequence Number: 6279864
• Product Code: BTR
• UDI-Device Identifier: 04026704398058
• UDI-Public: 04026704398058
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 5-22216
• Device Lot Number: 73J2300190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown