MAUDE Adverse Event Report: TELEFLEX HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL

Catalog Number 41893

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/03/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the nebulizer was blocked and did not mist.

Manufacturer Narrative

A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review could not be conducted since the lot number was not provided.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.Customer complaint cannot be confirmed based only on the information provided.However, current production was verified to identify any issue that can lead to the reported defect and no issues were found.If the device sample becomes available this investigation will be updated with the evaluation results.

• Brand Name: HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX; rtp NC
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4122183
• MDR Text Key: 4923435
• Report Number: 3004365956-2014-00355
• Device Sequence Number: 1
• Product Code: CCQ
• 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,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 41893
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1