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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 8830415001
Device Problems Difficult to Remove (1528); Defective Component (2292); Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intraoperatively, the guide wire that came with the kit was stuck in the catheter and did come out of the venous line (blue color) of the catheter. It was reported that the catheter has some blockage near the hub and because the guide wire was stuck inside the catheter. It was stated the flushing was done using normal saline and no abnormality was found. It was also stated that occlusion due to thrombosis was ruled out as the catheter was not reused. The catheter was not repaired, chlorhexidine gluconate was the cleaning agent used, tego was not utilized, there was no luer adapter issue and the insertion site was not treated prior to product placement. There was no patient injury.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one case of representative samples of the device. The visual inspection of the devi ce noted the catheter kit appeared intact. Pmv performed functional testing, the catheters were submerged into a water bath. The ends were clamped, and a syringe was used to inject air to observe leakage. No air bubbles were present. Both extensions were tested with acceptable results. The guide wire was inserted into the lumen and passed through without occlusion. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. If information is provided in the future, a supplemental report will be issued.
 
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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 Key8407609
MDR Text Key138368861
Report Number3009211636-2019-00056
Device Sequence Number1
Product Code FOZ
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
Report Date 05/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2021
Device Model Number8830415001
Device Catalogue Number8830415001
Device Lot Number1701100176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No

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