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

Catalog Number 121181-000070

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 333204953
• Report Number: 8040412-2024-00021
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 04026704012909
• UDI-Public: 04026704012909
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.