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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 Problems Hole In Material (1293); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges finding a hole in the circuit which caused a 2lpm leak.No report of a pt injury.
 
Manufacturer Narrative
A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review could not be conducted since the lot number was not provided.No corrective action can be established since the sample is not available, at the time of the report, to perform an investigation and determine the source of defect reported.This customer complaint can not be confirmed due to the lack of product sample to perform an investigation and determine the source of defect reported.If device sample becomes available at a later date this complaint will be re-opened.
 
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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, tamaulipas
MX 
Manufacturer Contact
margie burton, rn, regulatory af
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key4096905
MDR Text Key20297686
Report Number3004365956-2014-00311
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 User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/08/2014
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? No
Initial Date Manufacturer Received 07/08/2014
Initial Date FDA Received07/28/2014
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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