MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 AL W/040 ADAPTOR; BUBBLE HUMIDIFIER

Catalog Number 003-40

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the bottom of the bottle (device) cracked during use.The child was scared by the cracked bottle.Pt condition reported as fine.

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.A review of manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.All-in-process qa inspections were acceptable.No sample available from the customer to investigate.Root cause unk.Teleflex will continue to monitor feedback from the customers on issue related to water bottle getting cracked prior to or during use.

• Brand Name: HUDSON AQUAPAK 340 AL W/040 ADAPTOR
• Type of Device: BUBBLE HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; arlington heights IL
• Manufacturer (Section G): TELEFLEX; 900 west university dr.
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3950616
• MDR Text Key: 4613435
• Report Number: 1417411-2014-00041
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/30/2014

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: Other
• Device Catalogue Number: 003-40
• Device Lot Number: 044137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/05/2014
• 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