MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT W/COLUMN; ADULT HEATED-WIRE CIRCUIT KIT

Catalog Number 780-35KIT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that the column on the device is not allowing water to get into the heater.The alleged incident occurred during set-up on a patient.The device was changed out with another one.No report of a patient injury or delay in treatment.

Manufacturer Narrative

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

• Brand Name: HUDSON CIRCUIT W/COLUMN
• Type of Device: ADULT HEATED-WIRE CIRCUIT KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo, tamaulipas ; MX
• Manufacturer (Section G): TELEFLEX; ave. transformacion 5954; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, ra, clinical spec ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3802083
• MDR Text Key: 4479376
• Report Number: 3004365956-2014-00045
• 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: 12/20/2013

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: 12/20/2013
• Initial Date FDA Received: 01/10/2014
• 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