MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CORRUGATED COMFORT FLO REMOTE TEMP POR; CANNULA HUMIDIFICATION SYSTEM

Catalog Number 2416

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2015

Event Type  No Answer Provided  

Event Description

The customer alleges that the pressure valve did not activate.No report of patient injury or harm to a patient.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review could not be conducted since the lot number was not provided.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.Customer complaint cannot be confirmed due to the lack of product sample to perform a proper investigation and determine the root cause.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time.If the physical sample becomes available this complaint will be reopened.Note: a discussion with r & d engineer was conducted regarding the pressure relief valve.Per r & d, the flow rate for this set-up can be 1 to 8 lpm (ifu).The pressure relief valve is intended to activate above 8lpm in a patent set-up.Otherwise, if the set-up becomes kinked or obstructed the pressure would build up (above 8lpm) and would then activate the pressure valve.The water bottle may swell (at 1-8 lpm) without issue.From the complaint description, the pressure valve would not activate at 5-7lpm.

• Brand Name: HUDSON CORRUGATED COMFORT FLO REMOTE TEMP POR
• Type of Device: CANNULA HUMIDIFICATION SYSTEM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park; NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4534248
• MDR Text Key: 5356559
• Report Number: 3004365956-2015-00062
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2015

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: Health Professional
• Device Catalogue Number: 2416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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