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

Catalog Number 780-35KIT

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2014

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.No pt injury or delay in treatment reported.

Manufacturer Narrative

The device sample was not returned for eval at the time of this report.

• 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 ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3837704
• MDR Text Key: 4454505
• Report Number: 3004365956-2014-00126
• 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: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780-35KIT
• Device Lot Number: 0201302022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• 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