MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, HVT, 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048896
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: connector of ett could not stay on, kept popping off.So it had to be removed and the patient was reintubated with another ett.This occurred with 2 different patients on the same day, same problem, same solution to reintubate.No injury reported.(associated complaint 3003898360-2023-00145).
Additional Manufacturer Narrative
Qn#(b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10315 et tube, hvt, 7.5 for investigation.The returned et tube was visually examined with and without magnification.Visual examination of the returned et tube revealed that the connector was not returned.The returned sample appears used as there is biological material present on the device.The connector is originally seated loosely in the tube and not seating the connector firmly into the tube before use can cause it to disconnect.An indentation was present on the proximal end of the tube which indicates that the connector was inserted to the proper depth in the tube.Since the connector was not returned, it could not be determined if there were any issues with the connector.The ifu for this product states, "the 15 mm connector may be loosely seated due to the relaxation of the tube material around the connector.Seat the connector firmly in the tracheal tube.For a secure connection, the contacting surfaces must be clean and dry when seating the connector." "seat the 15 mm connector firmly in the adapter on the ventilator equipment to prevent disconnection during use.Ordinarily the security of the connection is increased by twisting the two elements together." "non-standard dimensions of some connectors on ventilator or anesthesia equipment may make it difficult to securely mate with the tracheal tube 15 mm connector.Use only the equipment having 15 mm connectors that are standard in compliance with iso 5356-1" the reported complaint could not be confirmed since the connector was not returned with the et tube.No issues were observed with the et tube.Teleflex will continue to monitor and trend on this issue.
Event or Problem Description
Reported event: connector of ett could not stay on, kept popping off.So it had to be removed and the patient was reintubated with another ett.This occurred with 2 different patients on the same day, same problem, same solution to reintubate.No injury reported.(associated complaint (b)(4).

• Brand Name: HUDSON ET TUBE, HVT, 7.5
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16283463
• Report Number: 3003898360-2023-00146
• Device Sequence Number: 17834339
• Product Code: BTR
• UDI-Device Identifier: 14026704616753
• UDI-Public: 14026704616753
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/09/2023

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 Model Number: IPN048896
• Device Catalogue Number: 5-10315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/28/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown