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

Model Number IPN044418

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported "incident happened in the ent surgery department.It happened during the use on a patient.The trach-vent involved had 2 valves.Thus, when we plugged it on the tracheal tube the patient was choking.In consequence the trach-vent was changed".No patient harm or injury reported.No patient desaturation reported.The condition of the patient is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was an extra silicone valve found inside the device.There is only one silicone valve available on this device.It is suspected the extra valve found inside the device is from the other valve, which is the aspiration valve as per stated in the information received by the customer.A device history record review was performed and no relevant findings were identified.It was determined the extra silicone valve found in the device may be due to mishandling during use, although this could not be confirmed.

Event Description

It was reported "incident happened in the ent surgery department.It happened during the use on a patient.The trach-vent involved had 2 valves.Thus, when we plugged it on the tracheal tube the patient was choking.In consequence the trach-vent was changed".No patient harm or injury reported.No patient desaturation reported.The condition of the patient is reported as "fine".

• Brand Name: HUDSON TRACH-VENT+,CLEAN
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11139018
• MDR Text Key: 225738674
• Report Number: 8040412-2021-00010
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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: No Information
• Device Model Number: IPN044418
• Device Catalogue Number: 41312
• Device Lot Number: 202030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1