MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. TRACH-VENT+,CLEAN; HUMID-VENT HEAT AND MOISTURE

Model Number IPN044418

Device Problem Compatibility Problem (2960)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It was reported that "we are using these trach-vent since july 2022.We are facing difficulty connecting to the tracheostomy tubes.Artificial noses do not connect to it (the orifice is too small)." further information states, "there was no consequence for the patient, no desaturation.The doctor did a diy system to make sure the trach-vent was connecting to the tube.".

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "we are using these trach-vent since (b)(6) 2022.We are facing difficulty connecting to the tracheostomy tubes.Artificial noses do not connect to it (the orifice is too small)".Further information states "there was no consequence for the patient, no desaturation.The doctor did a diy system to make sure the trach-vent was connecting to the tube.".

Manufacturer Narrative

(b)(4).Additional information received from the customer on 14 nov 2022 states "after investigation, we understood that it was a user error and not a failure of the device".Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: TRACH-VENT+,CLEAN
• Type of Device: HUMID-VENT HEAT AND MOISTURE
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15764230
• MDR Text Key: 303674019
• Report Number: 8040412-2022-00305
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 04026704348176
• UDI-Public: 04026704348176
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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 Operator: Health Professional
• Device Model Number: IPN044418
• Device Catalogue Number: 41312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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