MAUDE Adverse Event Report: TELEFLEX HUDSON SINGLE HEATED DUAL LIMB W DRAIN; BREATHING CIRCUIT

Catalog Number 880-34KIT

Device Problems Hole In Material (1293); Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that there was an audible leak in the circuit coming from a hole on the side of the water trap cup.No patient injury.

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 of batch number 02b1402461 was 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 specifications.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.This customer complaint can not be confirmed due to the lack of product sample to perform an investigation and determine the source of defect reported.If device sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON SINGLE HEATED DUAL LIMB W DRAIN
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; rtp NC
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4202404
• MDR Text Key: 4964124
• Report Number: 3004365956-2014-00342
• 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: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 880-34KIT
• Device Lot Number: 02B1402461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1