MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O

Catalog Number 780-36

Device Problems Leak/Splash (1354); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

The customer alleges that the rt checked the ventilator and found that the circuit was leaking.The wires had melted a hole in the plastic tubing.The circuit was changed and there was no patient injury.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received yet at our facility.A dhr (device history record) review could not be conducted since the lot number was not provided.No corrective action can be established at this moment since the device sample or a picture was not provided for evaluation.Customer complaint cannot be confirmed based only on the information provided.To perform an investigation and determine the source of defect reported, it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time.If device sample becomes available at a later date, this complaint will be reopened.

• Brand Name: HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo, tamaulipas ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd.; morrisville, NC 27506 ; 9194334965
• MDR Report Key: 4373717
• MDR Text Key: 21938480
• Report Number: 3004365956-2014-00421
• 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: 12/03/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 780-36
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/29/2014
• 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
• Patient Sequence Number: 1