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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 8832539003
Device Problem Obstruction of Flow (2423)
Patient Problem No Information (3190)
Event Date 02/18/2019
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 procedure, the guide wire was impossible to be inserted into the catheter due to an internal obstruction. The catheter was not repaired and tego was not utilized. There was no luer adapter issue and the insertion site was treated prior to product placement but no cleaning agent was used. There was no reported patient outcome.
 
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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 Key9382092
MDR Text Key180461044
Report Number3009211636-2019-00253
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521005358
UDI-Public10884521005358
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/10/2019
Device Model Number8832539003
Device Catalogue Number8832539003
Device Lot Number1428000123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2014
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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