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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON NEBULIZER; SMALL VOLUME DEBULIZER
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TELEFLEX HUDSON NEBULIZER; SMALL VOLUME DEBULIZER Back to Search Results
Catalog Number 41894
Device Problems Inaccurate Delivery (2339); Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the mask did not steam properly.No patient injury reported.
 
Manufacturer Narrative
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.The dhr (device history record) of batch number (b)(4) of material 41894 (nebulizer w/ped mask and tbg, small volume) was reviewed and no non conformance reports were originated for the lot in question that can be associate to the complaint reported.
 
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Brand Name
HUDSON NEBULIZER
Type of Device
SMALL VOLUME DEBULIZER
Manufacturer (Section D)
TELEFLEX
nuevo laredo, tamaulipas
MX 
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key3938097
MDR Text Key19922274
Report Number3004365956-2014-00125
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/21/2014
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 Health Professional
Device Catalogue Number41894
Device Lot Number02E1302318
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/03/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2014
Initial Date FDA Received03/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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