MAUDE Adverse Event Report: HUDSON HUMID-VENT 2S FLEX DC STERILE; CONDENSER, HEAT AND MOISTURE (

Model Number IPN042780

Device Problem Break (1069)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the nurse found the tube broken when using on patient which caused leaking".No injury or harm reported.Patient condition reported as "fine".

Event Description

It was reported that "the nurse found the tube broken when using on patient which caused leaking".No injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The manufacturer reports "in current manufacturing procedure, 100% leak testing and drop test are conducted at assembly area.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having broken product released for shipment.As simulation, (b)(4) pieces of the same catalog number in current production were taken to test if there is any defect.Result shows no defect found on (b)(4) pieces of visual inspected samples.All the (b)(4) pieces sample passed leak test and drop test." 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.

• Brand Name: HUDSON HUMID-VENT 2S FLEX DC STERILE
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• MDR Report Key: 12647054
• MDR Text Key: 276861609
• Report Number: 8040412-2021-00275
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 04026704347919
• UDI-Public: 04026704347919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN042780
• Device Catalogue Number: 17731
• Device Lot Number: 20AT28
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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: N/A.; N/A.