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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 8813793009
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intraoperatively, the catheter was clogged. It was stated that the cleaning agent used was chlorhexidine. It was also sated that bleeding occurred longer than scheduled. There was not reported patient injury.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a video evaluation of one device. A visual inspection of the returned video noted: during a surgical procedure the doctor is trying to insert the guide wire into the catheter. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intraoperatively, the end of the catheter was clogged. It was stated that the cleaning agent used was chlorhexidine alcohol. It was also stated that the catheter was flushed prior to use and normal flow was noted. They replaced the catheter with a new one to complete the case. There was not reported 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 Key8144316
MDR Text Key129754972
Report Number3009211636-2018-00384
Device Sequence Number1
Product Code FOZ
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 01/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/04/2022
Device Model Number8813793009
Device Catalogue Number8813793009
Device Lot Number1706100163
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2017
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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