MAUDE Adverse Event Report: TELEFLEX HUDSON NEONATE DUAL HEATED DUAL DRAIN; BREATHING CIRCUIT

Catalog Number 880-15KIT

Device Problems Leak/Splash (1354); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleged a leak in the circuit.With further review the customer noticed that the circuit had melted slightly in one area.The circuit was replaced and therapy continued.No complications or pt issues reported.

Manufacturer Narrative

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 (dhr) of batch number 02c1400244 has been reviewed and no issues or discrepancies were found related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specs.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed based only on the info provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.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 nor is it being manufactured at the time.If device sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON NEONATE DUAL HEATED DUAL DRAIN
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer Contact: margie burton, rn, regulatory af ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4219128
• MDR Text Key: 5000389
• Report Number: 3004365956-2014-00386
• Device Sequence Number: 1
• Product Code: CAG
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2014

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: 880-15KIT
• Device Lot Number: 02C1400244
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Treatment: VENTILATOR