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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 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received. The device and a photo were available for evaluation. Visual inspection noted the image of the device packaging with a orange band at he distal end, a yellow ban in the middle and another orange band at the proximal end with a note stapled. The devices noted that the device were received opened with yellow and orange bands around the body of the packaging. Only one device was still in the blue packaging paper. The catheters, introducer needles, straight stainless steel guide wires, dilators, wound dressings and sealing caps appeared intact. Functional testing found the catheters were submerged into a water bath. The ends were clamped, and a syringe was used to inject air to observe leakage and no air bubbles were present. Both extensions were tested with acceptable results. The guide wires were passed through the lumen and no occlusion was noted. It was reported that there was product damage. The reported issue could not be confirmed. The most likely cause could not be established from the information available. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, prior to use (after package opening and subsequent flushing with normal saline), it was stated that the devices lumen was found to be occluded (damage), there were no damage on the product and packaging upon receipt, it just opened and identified blocked lumen. There was no other parts of device missing, the device was sealed upon receipt, there was no patient involvement.
 
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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
lisa hernandez
15 hampshire street
mansfield, MA 02048
2034925563
MDR Report Key10936622
MDR Text Key219546746
Report Number3009211636-2020-00295
Device Sequence Number1
Product Code FOZ
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1901500092
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2019
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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