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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 8813793009
Device Problems Difficult to Remove (1528); Obstruction of Flow (2423)
Patient Problems No Patient Involvement (2645); Radiation Exposure, Unintended (3164); No Information (3190); No Code Available (3191)
Event Date 10/23/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, when inserting the catheter, the product did not pass through over the guide wire, it was reported that there was a blockage. There was no patient involvement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, when inserting the catheter (guide wire was already inside the patient), the product did not pass through over the guide wire as there was a blockage at the hub (the other end was not coming out) and they were unable to insert the catheter. Flushing was done with saline prior to use and heparinized saline was used prior and after to clean the catheter. They rejected the catheter and used another one to resolve the issue. There was no reported patient outcome.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, they punctured the vein and passed through the guide wire via the needle. They then retracted the needle and tried to insert the catheter over the guide wire but even before the catheter was inserted into the patient, the guide wire wasstuck at the hub (there was a blockage). The wire did not come out from the other end and they were unable to insert the catheter. It was mentioned that the guide wire used was the one included in the kit. Flushing was done with saline prior to use and heparinized saline was used prior and after to clean the catheter. Nothing unusual was observed on the device prior to use and there were no other defects/damages found on the product. It was necessary to remove the guide wire and catheter from the patient simultaneously (in one action) due to the alleged defect. The guide wire was still intact when it was removed (all pieces retrieved) and an ultrasound was performed to verify if all pieces were retrieved. They rejected the catheter and used another one to resolve the issue. There w as no blood loss and blood transfusion was not required.
 
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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 Key9277111
MDR Text Key165397007
Report Number3009211636-2019-00238
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521004801
UDI-Public10884521004801
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,Followup,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/20/2022
Device Model Number8813793009
Device Catalogue Number8813793009
Device Lot Number1729300128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/05/2019 Patient Sequence Number: 1
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