MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT,HEATED DUAL LIMB; RESPIRATORY GAS HUMIDIFIER

Catalog Number 780-32

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  malfunction  

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 at our facility.The device history record of batch number 74k1401864 that belong to catalog number 780-32 was reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.No corrective action can be established at this moment since the defective sample or picture are not 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 on this complaint.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the tube kinked.Patient condition reported as fine.

• Brand Name: HUDSON CIRCUIT,HEATED DUAL LIMB
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5143897
• MDR Text Key: 28040862
• Report Number: 3004365956-2015-00305
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/28/2015

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: No Information
• Device Catalogue Number: 780-32
• Device Lot Number: 74K1401864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2014
• 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