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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 Patient Involvement (2645)
Event Date 02/11/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, when the guide wire was passed over the lumen, it was found to be blocked. The catheter was not repaired and there was no leak. A solution was used to moisten the catheter. There was no luer adapter issue and the insertion site was not treated prior to product placement. There was no patient involvement.
 
Event Description
According to the reporter, prior to use (during testing), the venous (blue) line was found to be blocked when the guide wire was passed over the lumen. The catheter was not repaired and there was no leak. Saline solution was used to moisten the catheter and flushing was performed prior to insertion. There was no luer adapter issue and the insertion site was not treated prior to product placement. There was no problem with the catheter's dimension and nothing unusual was observed on the device prior to use. There were no other products being utilized with the device (only the installation kit). They had to change the catheter to resolve the issue. There was no patient involvement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key9775698
MDR Text Key194339028
Report Number3009211636-2020-00060
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793013
Device Catalogue Number8813793013
Device Lot Number1805800139
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2020
Is This a Reprocessed and Reused Single-Use Device? No

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