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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA MAH ELITE IC 12FR 20CM SE; DIALYSIS CATHETER
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COVIDIEN MANUFACTURING SOLUTIONS SA MAH ELITE IC 12FR 20CM SE; DIALYSIS CATHETER Back to Search Results
Model Number 8888221320
Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)
Patient Problem Thrombus (2101)
Event Date 07/02/2014
Event Type  Other  
Event Description
It was reported to covidien on (b)(6) 2014, that a customer had an issue with a dialysis catheter.The customer stes that the mahurkar elite catheters have clotted in 3 crrt patients.Two of the patients had to have the catheter exchanged out 3 times.One patient had to receive blood thinners due to the clotting.There was no change to the hospital staff's dialysis catheter protocol.Customer believes that the material on the mahurkar elite is different that the original mahurkar catheters.
 
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
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Brand Name
MAH ELITE IC 12FR 20CM SE
Type of Device
DIALYSIS CATHETER
Manufacturer (Section D)
COVIDIEN MANUFACTURING SOLUTIONS SA
alajuela
CS 
Manufacturer (Section G)
COVIDIEN MANUFACTURING SOLUTIONS SA
edificio 820 calle #2
zona franca coyol
alajuela 2010 1
CS   20101
Manufacturer Contact
lawrence rock
15 hampshire st.
mansfield, MA 02048
5082616625
MDR Report Key3982601
MDR Text Key15820158
Report Number3009211636-2014-00026
Device Sequence Number1
Product Code MSD
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
Reporter Occupation Other
Type of Report Initial
Report Date 07/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8888221320
Device Catalogue Number8888221320
Device Lot Number319935X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/09/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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