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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 Consequences Or Impact To Patient (2199)
Event Date 12/07/2019
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, on checking the device, it was reported that the guide wire was stuck inside the catheter and did not come out of the venous line of ultem adapter. It was stated that catheter had some blockage. A fresh pack of device was opened and used. The catheter was not repaired, there was no leak, chlorohexadine alcohol solution was the cleaning agent used, tego was not utilized and there was no luer adapter issue. There was no reported patient injury.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Additionally a photograph and video of the device were also received. A visual inspection of the returned photo noted: the image depicts the product identification label. A video was also received. The video depicts the surgeon inserting the guide wire into the distal end of the catheter. The guide wire is not able to pass through. A visual inspection of the returned product noted: the catheter, introducer needle, guide wire, dilators, wound dressing and sealing caps appeared intact. Pmv performed functional testing, the guide wire was inserted into the catheter, it passed through without occlusion. The catheter was submerged into a water bath. The end was clamped, and a syringe was used to inject air to observe leakage. No air bubbles were present. Both extensions were tested with acceptable results. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition. 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 Key9519269
MDR Text Key194786150
Report Number3009211636-2019-00283
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521004917
UDI-Public10884521004917
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 03/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/09/2021
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1700400156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No

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