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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE; NEBULIZER ADAPTOR FOR LG. VOL. NEBU.
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE; NEBULIZER ADAPTOR FOR LG. VOL. NEBU. Back to Search Results
Catalog Number 031-33J
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that device is not producing mist as intended.
 
Manufacturer Narrative
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.One (1) picture of catalog number 031-33j (nebulizer adaptor 033, sterile, japanese) was received for analysis.It was visually inspected and the fault reported by the customer is not clear in the picture.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE
Type of Device
NEBULIZER ADAPTOR FOR LG. VOL. NEBU.
Manufacturer (Section D)
TELEFLEX MEDICAL
nuevo laredo
MX 
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3900270
MDR Text Key4429454
Report Number3004365956-2014-00178
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number031-33J
Device Lot Number02H1300423
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/24/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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