MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FLEXI-SET CUFFED 7.5MM; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	504575
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the end connector on the ett becomes separated from the ett tube itself when attached to a vent circuit.This does not happen immediately but noticed it occurs when the tube is warm and moist.The end user then removes the original connector and replaces with a 1/2 size larger ett new connector which seems to alleviate the connection separation.The issue was identified during use on patient but there was no reported patient harm or consequence.Associated complaints 8040412-2024-00026, 8040412-2024-00061, 8040412-2024-00062, 8040412-2024-00063, 8040412-2024-00064, 8040412-20 24-00065, 8040412-2024-00066, 8040412-2024-00067, 8040412-2024-00068.
Additional Manufacturer Narrative
(b)(4).The sample was not returned to the manufacturer for investigation.The manufacturer reported "no sample was returned; thus, further investigation cannot be conducted.Without any sample, it is difficult to determine the root cause of this issue, thus this complaint could not be confirmed." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: the end connector on the ett becomes separated from the ett tube itself when attached to a vent circuit.This does not happen immediately but noticed it occurs when the tube is warm and moist.The end user then removes the original connector and replaces with a 1/2 size larger ett new connector which seems to alleviate the connection separation.The issue was identified during use on patient but there was no reported patient harm or consequence.Associated complaints (b)(4).

• Brand Name: FLEXI-SET CUFFED 7.5MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18709815
• Report Number: 8040412-2024-00069
• Device Sequence Number: 8357646
• Product Code: BTR
• UDI-Device Identifier: 04026704547623
• UDI-Public: 04026704547623
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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
• Device Catalogue Number: 504575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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