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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 8813817009
Device Problems Difficult to Remove (1528); Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intra- operatively, after cannulating the internal jugular vein, the guide wire was introduced into the patient and got stuck when passing through the venous tip end of the dialysis catheter, and did not come out of the venous ultem adapter ( blue color) end of the catheter. There was no patient injury.
 
Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device. Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition. 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, intra- operatively, after cannulating the internal jugular vein, the guide wire was introduced into the patient and got stuck when passing through the venous tip end of the dialysis catheter, and did not came out of the venous ultem adapter (blue colour) end of the catheter. It was noted the catheter was blocked and the entire catheter was replaced. There was no 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 Key8084097
MDR Text Key127548586
Report Number3009211636-2018-00354
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
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 01/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/21/2021
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1628800081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2016
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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