MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV

Catalog Number 1734

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges that the "nebulizer stops nebulizing after a few minutes".Alleged malfunction is reported during use.No report of patient harm or injury.

Manufacturer Narrative

(b)(4).The customer returned the actual sample along with 28 unused representative samples.A visual inspection was performed on the samples and no defects or anomalies were found.Approximately 3cc of water was injected into the jar of each kit.The samples were connected to a flowmeter and the airflow was increased to 8 lpm.Functional testing indicated a mist was produced from the chamber of each nebulizer.Each nebulizer began to sputter intermittently after approximately 5 minutes of nebulizing due to low volume of water in the jar to nebulize.The devices were tapped and rotated until they restarted.Based on the functional testing performed, there were no functional issues found with the returned samples.Additional inspection of the jet, jar, and cap were examined under the microscope which revealed no gross imperfections such as flash, debris or concentricity issues.The reported complaint that the nebulizer stops nebulizing after a few minutes could not be confirmed through functional inspection of the returned samples.The devices were tapped and rotated until they restarted.A dhr review was performed with no evidence to suggest a manufacturing related cause.There were no issues found with the returned samples.

Event Description

Customer complaint alleges that the "nebulizer stops nebulizing after a few minutes".Alleged malfunction is reported during use.No report of patient harm or injury.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6420264
• MDR Text Key: 70439049
• Report Number: 3004365956-2017-00104
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/15/2021
• Device Catalogue Number: 1734
• Device Lot Number: 74L1601536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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