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

Catalog Number 003-40J

Device Problems Decrease in Pressure (1490); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the flow of the device is very low and causes the pressure alarm to activate.

Manufacturer Narrative

Customer provided two photographs of defective sample.The first photo shows a side view of the nozzle.A small piece of the tip of the nozzle is cut off under a slight angle by a user (customer) probably to confirm a narrowing of port defect.There is also some excess flash on the top and bottom of the nozzle.The second photograph shows a front view of the nozzle.The image shows some plastic material buildup inside the nozzle that could impede a flow humidified gas coming out from the water bottle container.This is partially occluded nozzle defect.This defect is caused by falling parison or mis-adjusted holding jaws.A sample is needed to assess a degree of nozzle occlusion.A dimensional and functional inspection of the product involved in the complaint was not performed.A device history record review of mfg event log shows no issues that may have contributed to any quality issues reported.All process parameters were within spec and all in-process qa inspections were acceptable.Low occurrence defect.A sample is needed to determine root cause.Teleflex will continue to monitor feedback from the customers on issues related to occluded nozzle found at inspection on water bottle products.Mis-adjusted holding jaws or falling parison are possible causes of this defect.A sample is needed to determine root cause.

• Brand Name: HUDSON AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, JAP
• Type of Device: BUBBLE HUMIDIFIER
• Manufacturer (Section D): TELEFELX MEDICAL; arlington heights IL
• Manufacturer (Section G): TELEFELX; 900 west university dr.
• Manufacturer Contact: margie burton, rn, regulatory af ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3886396
• MDR Text Key: 4424323
• Report Number: 1417411-2014-00019
• 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: Foreign,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 003-40J
• Device Lot Number: 401137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2014
• 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