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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 Split (2537)
Patient Problem No Patient Involvement (2645)
Event Date 12/09/2014
Event Type  malfunction  
Event Description
The customer alleges that the circuit has a split in the seam.The tech noticed this alleged defect before installing on the ventilator.No patient injury reported.
 
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
research triangle park 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 Key4398571
MDR Text Key5120226
Report Number3004365956-2015-00015
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 12/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number880-34KIT
Device Lot Number74G1401890
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2014
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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