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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT, NEONATAL, 2IV, DUAL HTD LIMB, 60IN; BREATING CIRCUIT
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TELEFLEX MEDICAL HUDSON CIRCUIT, NEONATAL, 2IV, DUAL HTD LIMB, 60IN; BREATING CIRCUIT Back to Search Results
Catalog Number 780-18
Device Problems Leak/Splash (1354); Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2015
Event Type  malfunction  
Event Description
The customer alleges that the rt found the infant circuit with a leak from melted tubing.No report of patient injury or harm.
 
Manufacturer Narrative
(b)(4).The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
 
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Brand Name
HUDSON CIRCUIT, NEONATAL, 2IV, DUAL HTD LIMB, 60IN
Type of Device
BREATING CIRCUIT
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo, tamaulipas 8827 5
MX   88275
Manufacturer Contact
margie burton, rn reg. affairs
3015 carrington mill blvd.
morrisville, NC 27560
9194334965
MDR Report Key4651091
MDR Text Key5618195
Report Number3004365956-2015-00108
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 03/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number780-18
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/11/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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