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

Catalog Number 003-40J

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Per device history record review: 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 shows one non-conformance that has no impact on the quality issue reported.Non-conforming material was sorted for a defect, re-inspected, and found to be acceptable per internal specification.No sample available from the customer to investigate.Complaint not confirmed.Root cause unknown.Teleflex will continue to monitor customer feedback on this issue.

Event Description

The customer alleges an air leak from the connection between the adaptor and the bottle connector.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the humidifier adaptor was attached to the water bottle.The humidifier adaptor was properly assembled and there was no indication of damage to the threads on the snap cap that attaches the adaptor to the flow meter.No other issues were found.The water bottle and adaptor were attached to a flow meter and there was no air leak observed.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

The customer alleges an air leak from the connection between the adaptor and the bottle connector.

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,JAP
• Type of Device: NEBULIZER ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5689328
• MDR Text Key: 46228885
• Report Number: 1417411-2016-00069
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 003-40J
• Device Lot Number: 295157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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