MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048895
Medical Device Problem Codes	Inflation Problem (1310); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported issue: the tubes were tested prior to insertion, but it was not until pressure was applied, that the cuff did not stay inflated.A 2nd attempt on the patient to intubate the cuff did not stay inflated and pin holes were found in the cuff when they backed out.A 3rd attempt with a new tube was applied, cuff had pin holes and would not stay inflated.Pin holes were found once backed out.Additional information: patient had bleeding in the throat.Case was aborted and patient was sent to emergency room.Patient was admitted for 2 days with pneumothorax.
Additional Manufacturer Narrative
Qn#: (b)(4).A visual, dimensional, or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.No additional test was performed and the verification of failure mode reported in the current manufacturing process could not be performed due to the product not being manufactured.The device history review for et tube hvt 7.0 lot# 73m2100185 investigation did not show issues related to the complaint.Corrective actions cannot be established and the root cause cannot be determined since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

• Brand Name: ET TUBE, HVT, 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16014869
• Report Number: 3003898360-2022-00877
• Device Sequence Number: 17975390
• Product Code: BTR
• UDI-Device Identifier: 14026704616746
• UDI-Public: 14026704616746
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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 Model Number: IPN048895
• Device Catalogue Number: 5-10314
• Device Lot Number: 73M2100185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 51 YR
• Patient Sex: Male