MAUDE Adverse Event Report: TELEFLEX HUDSO0N DUAL HEATED DUAL DRAIN; ADULT BREATHING CIRCUIT

Catalog Number 880-36KIT

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that during integrity testing on the ventilator, the rt discovered a split connection to the iso-guard collection cup.No report of pt injury or harm.

Manufacturer Narrative

It is unk if the device sample is available for eval.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 (b)(4) has been reviewed and no issues or discrepancies were found relate 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: HUDSO0N DUAL HEATED DUAL DRAIN
• Type of Device: ADULT 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: 4219114
• MDR Text Key: 21933519
• Report Number: 3004365956-2014-00385
• 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: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 880-36KIT
• Device Lot Number: 74G1401842
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2014
• 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
• Treatment: VENTILATOR