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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED Back to Search Results
Model Number 8888233320
Medical Device Problem Codes Break (1069); Material Frayed (1262); Difficult to Remove (1528)
Health Effect - Clinical Code No Information (3190)
Date of Event 02/22/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during the procedure, the doctor inserted the catheter over the wire and upon retrieval, the doctor felt resistance and the guide wire began to come apart, kink and unwind.
 
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MAHURKAR ELITE
Common Device Name
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key7597119
Report Number3009211636-2018-00199
Device Sequence Number1799677
Product Code NIE
UDI-Device Identifier10884521127739
UDI-Public10884521127739
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K120674
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 06/25/2018
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
Operator of Device Health Professional
Device Model Number8888233320
Device Catalogue Number8888233320
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/14/2018
Supplement Date Received by Manufacturer06/22/2018
Initial Report FDA Received Date06/13/2018
Supplement Report FDA Received Date06/25/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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