MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT,HTD DUAL LIMB; HEATED - WIRE CIRCUIT

Catalog Number 780-35

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

The customer alleges that the circuit had a small melted area approximately 18 inches from the wye on the expiratory side.No patient in jury reported.

Manufacturer Narrative

Qn#(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A 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 is not available for evaluation.No photo available 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 nor is being manufactured at the time.If the device sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON CIRCUIT,HTD DUAL LIMB
• Type of Device: HEATED - WIRE CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4871234
• MDR Text Key: 6265389
• Report Number: 3004365956-2015-00174
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 780-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• 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
• Treatment: HEATER