MAUDE Adverse Event Report: TELEFELX HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, INT; HUMIDIFIER ADAPTOR

Catalog Number 400340

Device Problem Fitting Problem (2183)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the wing screw of the humidifier adaptor cannot be connected properly to the oxygen flow meter.Several attempts were made to connect to the flow meter.

Manufacturer Narrative

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 was conducted and the review of manufacturing event log showed no issues that my have contributed to any quality issues reported.All process parameters were within specification.All in-process qa inspections were acceptable.At the time of this report, no sample was available from the customer, to investigate.Teleflex will continue to monitor feedback from the customer on issues related to humidifier adaptor could not connect found at inspection on adaptor products.The complaint not confirmed.Root cause unknown.

• Brand Name: HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, INT
• Type of Device: HUMIDIFIER ADAPTOR
• Manufacturer (Section D): TELEFELX; rtp NC
• Manufacturer (Section G): TELEFLEX; 900 west university dr.
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27650 ; 9194334965
• MDR Report Key: 4219103
• MDR Text Key: 4999778
• Report Number: 1417411-2014-00067
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400340
• Device Lot Number: 362147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1