MAUDE Adverse Event Report: TELEFLEX HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUM; SMALL VOLUME NEBULIZER

Catalog Number 41894

Device Problems Restricted Flow rate (1248); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that tube is leaking so the mask could not create a mist.

Manufacturer Narrative

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 record was reviewed and showed that there were no issues related to this issue neither on the product nor its components during the manufacture of the material.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation, it is necessary to evaluate the sample involved on the incident.The customer complaint cannot be confirmed based only on the information provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If the defective sample becomes available this investigation will be updated with the evaluation results.

• Brand Name: HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUM
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3886545
• MDR Text Key: 4427362
• Report Number: 3004365956-2014-00167
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2014

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: Health Professional
• Device Catalogue Number: 41894
• Device Lot Number: 02L1301686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1