MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER,NEBULIZER KIT

Catalog Number 003-40F

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not received yet at our facility, at the time of this report.No photos have been received for evaluation of the alleged defect reported.Based on the arlington heights lot number provided, the nuevo laredo lot numbers for component (b)(4) were obtained.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint (b)(4) during the manufacture of the material.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation and determine the source of the alleged defect reported, it is necessary to evaluate the device sample involved in this complaint.No corrective action can be established at this time.If the device sample becomes available at a later date this report will be updated accordingly.

Event Description

Customer complaint alleges "oxygen leaks and the connection part breaks." alleged defect reported as detected during use.No report of patient harm.Patient condition reported as "fine".

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE
• Type of Device: HUMIDIFIER,NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6657621
• MDR Text Key: 78095977
• Report Number: 1417411-2017-00032
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/05/2020
• Device Catalogue Number: 003-40F
• Device Lot Number: 634167
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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