MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 709 FNS,760 ML; NEBULIZER

Catalog Number 037-09

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2016

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.A device history review could not be performed; no lot number was supplied by the customer.No sample available from the customer to investigate.Root cause is unknown.Teleflex will continue to monitor feedback from the customers on issues related to insufficient aerosol on water bottle products.

Event Description

The customer alleges that the unit does not produce sufficient aerosol.This issue is causing a drying of the trach/et tube.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed on the lot number reported (127150).There were no issues found that may have contributed to any quality issues reported.All process parameters were within specification and all in-process qa inspections were acceptable.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the unit does not produce sufficient aerosol.This issue is causing a drying of the trach/et tube.

• Brand Name: HUDSON AQUAPAK 709 FNS,760 ML
• 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: 5374290
• MDR Text Key: 36248021
• Report Number: 1417411-2016-00008
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

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: No Information
• Device Catalogue Number: 037-09
• Device Lot Number: 127150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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