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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8813793013
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, before the catheter was passed to the patient and the doctor tried to pass the guide wire to test the route, the guidewire did not progress within the catheter. They had to replace the catheter with another one to complete the implantation. The catheter was not repaired and there was no leak. There was no cleaning agent used on the device, tego was not utilized, and there was no luer adapter issue. Nothing unusual was observe don the device prior to use except that the guide wire did not progress and there was no damage to the device's box or packaging (integral packaging). There were no other visible defect/damage observed and flushing was not performed. There was no problem with the catheter's dimension and there was an occlusion in the guide wire passage. There were no other products being utilized with the device and all pieces were accounted for and no imaging exam was required. There were no patient symptoms or complications associated with this event, no medical or surgical intervention needed to prevent permanent impairment of a function, and it did not lead to or extend patient hospitalization. There was no patient injury.
 
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Brand NameMAHURKAR
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
lisa hernandez
15 hampshire street
mansfield, MA 02048
2034925563
MDR Report Key9540745
MDR Text Key189914125
Report Number3009211636-2020-00005
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521004832
UDI-Public10884521004832
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793013
Device Catalogue Number8813793013
Device Lot Number1621100150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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