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

Model Number	IPN044418
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem 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.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 8040412-2022-00305
• Device Sequence Number: 8193147
• Product Code: BYD
• UDI-Device Identifier: 04026704348176
• UDI-Public: 04026704348176
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/08/2022
• 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
• Patient Sex: Unknown