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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O; BREATHING CIRCUIT

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TELEFLEX HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O; BREATHING CIRCUIT Back to Search Results
Catalog Number 780-36
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 06/23/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the circuit leaked during pre-testing and prior to patient use.
 
Manufacturer Narrative
The device sample was not returned for eval at the time of the report.
 
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Brand Name
HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer Contact
margie burton, rn, ra
po box 12600
durham, NC 27709
9194334965
MDR Report Key4019900
MDR Text Key4712846
Report Number3004365956-2014-00264
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 06/23/2014
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 Number780-36
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2014
Initial Date FDA Received07/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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