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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; SMALL VOLUME NEBULIZER
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TELEFLEX HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; SMALL VOLUME NEBULIZER Back to Search Results
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
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.The device history record was reviewed and there were no issues related to this issue on the product nor its components during the manufacture of the material.All personnel from the production line will be notified to make them aware of this issue.
 
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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 Key3904695
MDR Text Key4429186
Report Number3004365956-2014-00199
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received05/27/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1882
Device Lot Number02B1401880
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/20/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received05/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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