MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,8.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048875
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: the ed physician intubated a patient and had difficulty with the tube.Respiratory checked the balloon prior to intubation and it inflated properly.After introducing the tube, it would not hold air.This happened on 2 different et tubes, 3rd held air.The tube is a 7.5mm hudson rci tube, lot 73d220280 with a 04/10/2027 expiration.This same situation happened with two other 8.0 tube et tubes.The reported defect was detected during use on patient.
Additional Manufacturer Narrative
Qn#(b)(4).The device history review for the et tube,cf,8.5 lot # 73e2000318 was manufactured on 05/19/2020 a total of 5,800 pieces.Lot was released on 05/27/2020.Dhr investigation did not show issues related to complaint.

• Brand Name: ET TUBE,CF,8.5
• 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: 16122646
• Report Number: 3003898360-2023-00079
• Device Sequence Number: 12388403
• Product Code: BTR
• UDI-Device Identifier: 14026704616548
• UDI-Public: 14026704616548
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/22/2022

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: 05/18/2025
• Device Model Number: IPN048875
• Device Catalogue Number: 5-10117
• Device Lot Number: 73E2000318
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown