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

Catalog Number 003-40J

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

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 by the manufacturer at the time of this report.Device history record review 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.Complaint cannot be confirmed as there is no device sample to evaluate at this time.If the device sample becomes available at a later date, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "it was reported that bubbling from sterilized water could not be confirmed during use." no patient injury was reported.Patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).One empty 340 ml water bottle was received for evaluation.It came used with the 040 humidifier adaptor attached to the bottle.Upon visual inspection, there is a channel from the bottom of the adaptor port to the top of the bottle.The water bottle was filled 3/4 full with water.The water bottle/adaptor assembly was applied to a flow meter.The flow meter was set to 1 1pm and no bubbles were observed in the bottle.Upon increasing the air flow, bubbles appeared in the bottle.Customer complaint is confirmed, based on the investigation results.A non-conformance is opened to address this issue.

Event Description

Customer complaint alleges "it was reported that bubbling from sterilized water could not be confirmed during use." no patient injury was reported.Patient condition was reported as "fine".

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,JAP
• Type of Device: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7597286
• MDR Text Key: 111013825
• Report Number: 1417411-2018-00038
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/11/2021
• Device Catalogue Number: 003-40J
• Device Lot Number: 470177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1