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

Catalog Number 41893

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/29/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that the device does not produce a mist/steam when in use.No report of a pt injury or delay in treatment.

Manufacturer Narrative

A visual, dimensional and functional inspection of ther product involved in the complaint could not be conducted since the product was not returned.The dhr (device history record) of batch number 02e1300979 was reviewed and no issues or discrepancies were found which could potentially related to this complaint.No rejection reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.No corrective action can be established at this moment since the defective sample or a picture of it are not available for evaluation.The customer complaint cannot be confirmed due to the lack of product sample to perform a proper investigation and determine the root cause.If the physical sample become available this complaint will be reopened.

• Brand Name: HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL
• Type of Device: SMALL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo, tamaulipas ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, clinical speciali ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3647377
• MDR Text Key: 4356024
• Report Number: 3004365956-2014-00007
• 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,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 41893
• Device Lot Number: 02E1300979
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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