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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 11/10/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during the insertion procedure, the guide wire got stuck in the catheter when it was passed through the venous tip of the catheter and guide wire did not come out of the venous line (blue ultem adapter) of the dialysis catheter. Doctor had to remove the catheter along with guide wire and new catheter was used to the patient. Catheter was not repaired, there was no leak, tego was not utilized, luer adapter had no issue. 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 st.
mansfield, MA 02048
2034925563
MDR Report Key9435301
MDR Text Key180461053
Report Number3009211636-2019-00261
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521004917
UDI-Public10884521004917
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,Followup
Report Date 03/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/29/2021
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1633400076
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
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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