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

Catalog Number 41312U

Device Problems Suction Problem (2170); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

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 still in progress.

Event Description

Customer complaint alleges the suction port of the trach-vent was blocked.Alleged issue reported as detected during use.It was reported there were no consequences for the patient.The device was changed with another.Patient condition 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 no slit on the silicone valve.A device history record review was performed and there were no issues found that could relate to the reported complaint.Based on the visual exam, the complaint was confirmed.A non-conformance has been opened to further address this issue.

Event Description

Customer complaint alleges the suction port of the trach-vent was blocked.Alleged issue reported as detected during use.It was reported there were no consequences for the patient.The device was changed with another.Patient condition reported as "fine".

• Brand Name: HUDSON TRACH-VENT+CLEAN
• 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: 7490382
• MDR Text Key: 107466196
• Report Number: 8040412-2018-00116
• Device Sequence Number: 1
• Product Code: BYD
• 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,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

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 Catalogue Number: 41312U
• Device Lot Number: 201741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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