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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 Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2018
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 use, when connecting the lines for the patient to receive the immune adsorption treatment, the catheter was tapped.The patient had an x-ray that confirmed that the catheter was in place.An anti thrombotic was about to be used when the nurse saw the 2 lumens of the device were full of air.It was stated that they had to remove the catheter.There was no patient injury.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.A review of the device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during use, when connecting the lines for the patient to receive the immune adsorption treatment, the catheter was tapped.It was stated that before connecting the patient for the treatment, an obstruction was noticed when controlling the line.The line was difficult to flush and there was no blood flashback.After withdrawing the access, a clot was noticed during the flushing.Reverse of the line was not done since the treatment was not successfully connected.The patient had a control x-ray that confirmed that the catheter was in place.An anti thrombotic (altéplase) was about to be used when the nurse saw that both extensions of the device were full of air.It was stated that they had to remove the catheter.There was no patient injury.
 
Manufacturer Narrative
Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during use, when connecting the lines for the patient to receive the immune adsorption treatment, the catheter was tapped.It was stated that before connecting the patient for the treatment, an obstruction was noticed when controlling the line.The line was difficult to flush and there was no blood flashback.After withdrawing the access, a clot was noticed during the flushing.Reverse of the line was not done since the treatment was not successfully connected.The patient had a control x-ray that confirmed that the catheter was in place.An anti thrombotic (altéplase) was about to be used when the nurse saw that both extensions of the device were full of air.It was stated that they had to remove the catheter.There was no patient injury.
 
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Brand Name
MAHURKAR
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key8089037
MDR Text Key127874737
Report Number3009211636-2018-00356
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier20884521004914
UDI-Public20884521004914
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 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8813817009
Device Catalogue Number8813817009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Date Manufacturer Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age15 YR
Patient Weight59
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