MAUDE Adverse Event Report: TELEFLEX MEDICAL LARYNGOFLEX WITHOUT FIXATION FLANGE; TUBE, TRACHEOSTOMY (W/WO CONN

Catalog Number	121181-000070
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the connector got detached from the tube by itself during use on a patient, immediately after insertion.Therefore, the user fixed it with zip tie.No injury to the patient occurred.
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer.The manufacturer reported: "an actual sample was received for further evaluation.Based on evaluation, the tube can be detached from the connector.The tube was observed with no glue marking on inner side of tube and outer side of connector.Further review on product catalog, the assembled tube was supplied by external supplier.Based on the investigation, the defect mode matches with the complainant.Hence, further investigation and corrective action will be documented." teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported that the connector got detached from the tube by itself during use on a patient, immediately after insertion.Therefore, the user fixed it with zip tie.No injury to the patient occurred.

• Brand Name: LARYNGOFLEX WITHOUT FIXATION FLANGE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONN
• Manufacturer (Section D): TELEFLEX MEDICAL; 71394 kernen
• 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: 18526714
• Report Number: 8040412-2024-00021
• Device Sequence Number: 20732270
• Product Code: BTO
• UDI-Device Identifier: 04026704012909
• UDI-Public: 04026704012909
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

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
• Device Catalogue Number: 121181-000070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 04/23/2024
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown