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
Event or Problem Description
It was reported "the end connector on the ett becomes separated from the ett tube itself when attached to a vent circuit.Noticed it occurs when the tube is warm and moist." the original connector was removed and replaced with a larger connector.No patient harm or injury.No medical intervention required.The patient current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for investigation.The manufacturer reported: "an actual sample was received for evaluation.The actual sample was able to detach with extra forces in room temperature.Upon detachment, outer diameter of connector was observed with a clean surface and no contamination observed.Tube insertion depth and connector outer diameter was measured.The result shown all within specification, thus wrong connector size assembled to tube can be ruled out.The bonding test was passed and within specification.The affected lot shown strong attachment of bonding strength test with an average more than 200n.Hence, the possibilities of connector detached from tube can be ruled as bonding strength test conducted passed the acceptance criteria.Based on the investigation conducted, the defect mode of connector separated from et tube matches with the complainant report.However, review bonding strength test for the affected lot and the results above the acceptance criteria." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "the end connector on the ett becomes separated from the ett tube itself when attached to a vent circuit.Noticed it occurs when the tube is warm and moist." the original connector was removed and replaced with a larger connector.No patient harm or injury.No medical intervention required.The patient current condition is reported as "fine".

• 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: 18658436
• Report Number: 8040412-2024-00026
• Device Sequence Number: 7297896
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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
• Device Catalogue Number: 504575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/29/2024
• 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: VENTILATOR; VENTILATOR
• Patient Sex: Unknown