MAUDE Adverse Event Report: TELEFLEX HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; SMALL VOLUME NEBULIZER

Catalog Number 1882

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that while preparing the nebulizer for use, it was discovered that the mouthpiece of the device was missing from the package.The patient's safety and well being was not jeopardized.

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 lot number was not provided, therefore, it is not possible to determine in which conditions this material was manufactured.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, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.However, all personnel from the production line will be notified to make them aware of this issue.If the defective sample becomes available this investigation will be updated with the evaluation results.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3904682
• MDR Text Key: 4429188
• Report Number: 3004365956-2014-00200
• 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: Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/12/2014

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: Other
• Device Catalogue Number: 1882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1