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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 Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
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 guidewire was stuck inside the catheter and did come out of the venous line ultem adapter ( blue color ) of the catheter. They also stated that healthcare professional mentioned that the guidewire was stuck because the catheter had some blockage. There was no leak and no luer adapter issue. The catheter was not repaired and tego was not utilized. A fresh pack of the catheter was opened and used. 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
CS 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
CS 20101
Manufacturer Contact
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key12602664
MDR Text Key275868404
Report Number3009211636-2021-00285
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 Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1927500094
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2019
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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