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

Catalog Number 780-35KIT

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the ventilator circuit is disconnecting from the extension limb.The patient's condition is reported as fine.

Manufacturer Narrative

A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product wasn ot returned.The device history record review showed that there were no issues related to this issue neither on the product nor its components during the mfr of the material.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If the defective sample becomes available, this investigation will be updated with the eval results.

• 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, regulatory af ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3818380
• MDR Text Key: 4389923
• Report Number: 3004365956-2014-00157
• 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: 03/17/2014

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
• Device Lot Number: 02A1400716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1