MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONFORT FLO HUMIDIFICATION SYSTEM; CANNULA HUMIDIFICATION SYSTEM

Catalog Number 2414

Device Problem Crack (1135)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

The customer alleges that the circuit is cracking at the temperature port and/or at the other end of the connector.The alleged defect occurred during pre-test.No patient injury reported.

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.The device history record was reviewed and there were no issues related to functional issues on the product or its components during the manufacture of the material.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 based only on the information provided, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.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 device sample becomes available this investigation will be updated with the evaluation results.

• Brand Name: HUDSON CONFORT FLO HUMIDIFICATION SYSTEM
• 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 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4490988
• MDR Text Key: 5328006
• Report Number: 3004365956-2015-00055
• Device Sequence Number: 1
• Product Code: CAT
• 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: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/15/2019
• Device Catalogue Number: 2414
• Device Lot Number: 74K1400074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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