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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON NEONATE DUAL HEATED DUAL DRAIN; BREATHING CIRCUIT
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TELEFLEX HUDSON NEONATE DUAL HEATED DUAL DRAIN; BREATHING CIRCUIT Back to Search Results
Catalog Number 880-15-KIT
Device Problem Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the circuit melted together during use on a patient.No report of a patient injury.
 
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 (dhr) of batch number 02b1401846 has been reviewed and no issues or discrepancies were found related to this complaint.No non-conformance 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.
 
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Brand Name
HUDSON NEONATE DUAL HEATED DUAL DRAIN
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer (Section G)
TELEFLEX MEDICAL
ave. industrias no.5954
parque industrial finsa
nuevo laredo, tamaulipas
MX  
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key4174449
MDR Text Key15325439
Report Number3004365956-2014-00316
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 07/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number880-15-KIT
Device Lot Number02B1401846
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/28/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/18/2014
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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