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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SINGLE HEATED DUAL LIMB W DRAIN; BREATHING CIRCUIT
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TELEFLEX MEDICAL HUDSON SINGLE HEATED DUAL LIMB W DRAIN; BREATHING CIRCUIT Back to Search Results
Catalog Number 880-34KIT
Device Problem Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2014
Event Type  malfunction  
Event Description
The customer alleges that the iso-gard drain on the expiratory side of the circuit could not be suctioned.No report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
HUDSON SINGLE HEATED DUAL LIMB W DRAIN
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX MEDICAL
rtp NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo, 8827 5
MX   88275
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key4402123
MDR Text Key18270194
Report Number3004365956-2015-00041
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 12/18/2014
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 Number880-34KIT
Device Lot Number02C1400246
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2014
Initial Date FDA Received01/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
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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