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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEONATE DUAL HEATED DUAL DRAIN; BREATHING CIRCUIT
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TELEFLEX MEDICAL HUDSON NEONATE DUAL HEATED DUAL DRAIN; BREATHING CIRCUIT Back to Search Results
Catalog Number 880-15KIT
Device Problem Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the circuit slowly melted during use.The patient was bagged while a new circuit was placed on the patient.No report of patient injury.The patient condition is reported as fine.
 
Manufacturer Narrative
The device was received by the manufacturer, but the investigation is incomplete at the time of this report.A dhr (device history record) review could not be conducted since the lot number was not provided.
 
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Brand Name
HUDSON NEONATE DUAL HEATED DUAL DRAIN
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX MEDICAL
nuevo laredo
MX 
Manufacturer (Section G)
TELEFLEX
ave. transsformacion 5954
parque industrial finsa
nuevo laredo
MX  
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3900218
MDR Text Key21174259
Report Number3004365956-2014-00177
Device Sequence Number1
Product Code CAG
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/15/2014
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 Health Professional
Device Catalogue Number880-15KIT
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/17/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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