MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 400 SW,440 ML,JAPAN; NEBULIZER

Catalog Number 004-00J

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

(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.The device history review was conducted and 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.The complaint cannot be confirmed since the sample was not available for investigation.The root cause is unknown.Teleflex will continue to monitor feedback from the customers on issues related to this complaint description.

Event Description

The customer alleges that oxygen and humidification were not delivered to the patient.The patient's condition is reported as good and no additional therapy was needed.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the water bottle was used and showed that the top port and side port were punctured.There was no blockage in these openings.The adaptor used with the water bottle was not received.No other issues were found.Functional testing could not be performed as the adaptor used to puncture the water bottle was not received, thus the complaint could not be confirmed.

Event Description

The customer alleges that oxygen and humidification were not delivered to the patient.The patient's condition is reported as good and no additional therapy was needed.

• Brand Name: HUDSON AQUAPAK 400 SW,440 ML,JAPAN
• Type of Device: NEBULIZER
• 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: 5722579
• MDR Text Key: 47300340
• Report Number: 1417411-2016-00086
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• 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: 004-00J
• Device Lot Number: 049154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1