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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 8888231224
Medical Device Problem Code Product Quality Problem (1506)
Health Effect - Clinical Code Cardiac Arrest (1762)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, an unspecified issue was noted post femoral artery catheter insertion.It was stated that the heart was being spiked and the patient had an arrest for a short time.It was mentioned in the report that the insertion site was treated with an unknown cleaning agent prior to product placement.The catheter was not repaired, there was no leak and there was no luer adapter issue.There was no reported patient outcome.
 
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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 Key9337583
Report Number3009211636-2019-00245
Device Sequence Number13915797
Product Code NIE
UDI-Device Identifier10884521127449
UDI-Public10884521127449
Combination Product (Y/N)N
Initial Reporter CountryHK
PMA/510(K) Number
K120674
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number8888231224
Device Catalogue Number8888231224
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/01/2019
Initial Report FDA Received Date11/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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