MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONFORT FLO HUMIDIFICATION SYSTEM; RESPIRATORY GAS HUMIDIFIER

Catalog Number 2414

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation codes: a conclusion(s) code could not be chosen.The complaint was confirmed, but the root cause is unknown.Two pictures of product p/n 2414 (confort flo humidification system with) was received for analysis.It was visually inspected, finding a foreign material in circuit.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The part number 12251 is a component of the code part number 2414.For that reason the device history record of batch number (b)(4) that belong to part number 12251 has been 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 since the sample is not available to perform an investigation and determine the source of defect reported.Other remarks: the customer complaint was confirmed based on the visual inspection of the received picture, and a foreign material was detected in circuit.Although the complaint is confirmed based on pictures provided, there is no sufficient evidence to assure this issue was originated during the manufacturing process.The root cause for the condition reported could not be identified.Nuevo laredo facility will continue to track and trend this failure mode.If device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that a piece of metal was observed in the device.No patient injury reported.

• Brand Name: HUDSON CONFORT FLO HUMIDIFICATION SYSTEM
• 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: 5353490
• MDR Text Key: 35686958
• Report Number: 3004365956-2016-00016
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2414
• Device Lot Number: 74H1402704
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2015
• 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