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

Catalog Number 10011

Device Problem Restricted Flow rate (1248)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product usage when the alleged issue was detected is unknown.It is unknown if the device sample is available for evaluation.

Event Description

The customer alleges that the airflow is restricted.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed on the lot number reported and there were no issues found that could relate to the reported complaint.No sample was returned for evaluation; therefore, the complaint could not be confirmed.In the current manufacturing procedure, 100% drop testing is conducted at the assembly area, therefore, any defects would be detected prior to release.Ten pieces of the same catalog number were taken from current production.All ten samples passed the drop testing.This indicates that there is no blockage on the products.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the airflow is restricted.

Manufacturer Narrative

(b)(4).Device not returned to manufacturer.

Event Description

The customer alleges that the airflow is restricted.

• Brand Name: HUDSON HUMID-VENT MINI
• 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: 5168369
• MDR Text Key: 28935797
• Report Number: 8040412-2015-00214
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2015

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: 11/30/2019
• Device Catalogue Number: 10011
• Device Lot Number: 14KT10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 10/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/01/2015; 12/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2014
• 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