MAUDE Adverse Event Report: TELEFLEX HUDSON 780-35 CIRCUIT W/COLUMN; BREATHING CIRCUIT

Catalog Number 780-35KIT

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the column is not allowing water to get into the heater.The device was changed out for another one.No patient harm or delay in treatment to the patient.

Manufacturer Narrative

A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review could not be conducted since the lot number was not provided.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.The customer complaint cannot be confirmed based only with the information provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If defective sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON 780-35 CIRCUIT W/COLUMN
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3824748
• MDR Text Key: 4401889
• Report Number: 3004365956-2014-00078
• 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: 01/28/2014

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: 780-35KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1