MAUDE Adverse Event Report: TELEFLEX HUDSON VENTILATOR CIRCUIT, UNIVERSAL NEONATAL W; BREATHING CIRCUIT

Catalog Number 780-10

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the circuit failed the leak test.The customer reports that the circuit is broken.

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 (dhr) of batch number (b)(4) has been reviewed and no issues or discrepancies were found relate 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 cannot be confirmed due to the lack of product sample to perform an investigation and determine the source of defect reported.If defective sample becomes available at a later date this complaint will be reopened.

• Brand Name: HUDSON VENTILATOR CIRCUIT, UNIVERSAL NEONATAL W
• 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: 3908288
• MDR Text Key: 4584812
• Report Number: 3004365956-2014-00197
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/13/2014

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: Other
• Device Catalogue Number: 780-10
• Device Lot Number: 02J1300337
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1