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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON ANESTHESIA CIRCUIT, ADULT, HEATED WIRE; ADULT BREATHING CIRCUIT
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TELEFLEX HUDSON ANESTHESIA CIRCUIT, ADULT, HEATED WIRE; ADULT BREATHING CIRCUIT Back to Search Results
Catalog Number 780-35
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 07/07/2014
Event Type  malfunction  
Event Description
The complaint is reported as: the circuit would not pass the leak test.The issue was detected prior to pt use.
 
Manufacturer Narrative
A device history record (dhr) review was performed and there were no issues found that could relate to the reported 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 specifications.The sample was not returned for evaluation, therefore, the complaint could not be confirmed.If the sample is received, a follow-up report will be submitted with the investigation results.
 
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Brand Name
HUDSON ANESTHESIA CIRCUIT, ADULT, HEATED WIRE
Type of Device
ADULT BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo, tamaulipas
MX 
Manufacturer Contact
katharine tarpley, reg affairs
p.o. box 12600
rtp, NC 27709
9194334854
MDR Report Key4177427
MDR Text Key5100630
Report Number3004365956-2014-00294
Device Sequence Number1
Product Code CAI
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 07/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number780-35
Device Lot Number74D1400568
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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