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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 8813793013
Device Problem Obstruction of Flow (2423)
Patient Problem No Patient Involvement (2645)
Event Date 08/05/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, there was obstruction found in the passage of the guide wire during catheter insertion.It was noted that the catheter was not repaired, there was no leak, no luer adapter issue and flushing was not done.It was stated that the occlusion was found next to the suture fin.There was no defect or damage found in the guide wire.Another kit was used to complete the procedure.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, there was obstruction found in the passage of the guide wire prior to catheter insertion.It was noted that the catheter was not repaired, there was no leak, no luer adapter issue and flushing was not done.It was stated that the occlusion was found next to the suture fin.There was no defect or damage found in the guide wire.The catheter was not inserted.Another kit was used to complete the procedure.There was no patient involvement.
 
Event Description
According to the reporter, there was obstruction found in the passage of the guide wire during catheter insertion.It was noted that the catheter was not repaired, there was no leak, no luer adapter issue and flushing was not done.It was stated that the occlusion was found next to the suture fin.There was no defect or damage found in the guide wire.The catheter was not inserted.Another kit was used to complete the procedure.There was no patient involvement.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of video graphic evaluation of one device.The visual inspection of the returned video noted: the surgeon is inserting a guide wire into the distal end of the cannula.He then proceeds to pull back on the guide wire and push back in several times.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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.
 
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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 Key9109286
MDR Text Key159798567
Report Number3009211636-2019-00204
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10884521004832
UDI-Public10884521004832
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,distri
Type of Report Initial,Followup,Followup,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2022
Device Model Number8813793013
Device Catalogue Number8813793013
Device Lot Number1717000107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Initial Date Manufacturer Received 08/29/2019
Initial Date FDA Received09/24/2019
Supplement Dates Manufacturer Received10/11/2019
11/19/2019
12/18/2019
Supplement Dates FDA Received10/28/2019
12/08/2019
01/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
Patient Weight71
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