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

Catalog Number 880-36KIT

Device Problems Crack (1135); Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

The customer alleges that there is a split/crack on the circuit tube at the connection interface.The alleged issue was detected at the time of testing/set-up.No pt injury.

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 showed that there were no issues related to functional issues neither on the product nor its components during the mfr of the material.No corrective action can be established at this time since the defective sample or a picture is available for evaluation.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 DUAL HEATED DUAL DRAIN
• Type of Device: ADULT BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research traingle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; 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: 4339732
• MDR Text Key: 16182405
• Report Number: 3004365956-2014-00414
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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