MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TRACH-VENT; CONDENSER, HEAT AND MOISTURE (

Catalog Number 41112

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is in progress.

Event Description

Customer complaint alleges "vent will fly off or fall out easily when patient coughs or sneezes.".

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The actual sample was not returned; however, the customer did return a representative sample for evaluation.A visual exam was performed on the representative sample and no defects were observed.In the current manufacturing procedure, a 100% visual inspection is conducted after the assembly process; thus, any defects would be detected prior to release from the manufacturing facility.The complaint could not be confirmed as the actual device was not returned for investigation.

Event Description

Customer complaint alleges "vent will fly off or fall out easily when patient coughs or sneezes.".

• Brand Name: HUDSON TRACH-VENT
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7048316
• MDR Text Key: 93296800
• Report Number: 8040412-2017-00234
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

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 Expiration Date: 02/12/2022
• Device Catalogue Number: 41112
• Device Lot Number: 201707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 12/27/2017
• 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