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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

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COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Model Number 8888145014
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2020
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, part the red (arterial) luer adapter thread was cracked and broken off.Catheter was no longer in functional condition for dialysis.Betadine was the cleaning agent used on the catheter.There was no leak, no tego utililized and no instrument used to loosen or tighten the device.Catheter was not repaired.There was no patient injury.
 
Event Description
According to the reporter, during use, part the red (arterial) luer adapter thread was cracked and broken off.The piece of the luer adapter fell off the ground.Catheter was no longer in functional condition for dialysis.Damaged catheter was removed and a new one was used.The adapter was tighten using hand.Betadine was the cleaning agent used on the catheter and allowed to dry thoroughly prior to applying ointment(s) to the area and it was also used to clean the adapters.There was no leak, no tego utililized and no instrument used to loosen or tighten the device.No intervention or treatment required.Catheter was not repaired and there was no blood loss noted.There was nothing unusual observed on the device prior to use and no other products being utilized with the device.There was no patient injury.
 
Manufacturer Narrative
Additional information: b5, d10, g4, h3, h6.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
Additional information: g4, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the luer adapter was found to be cracked with a piece missing.It was reported that the luer adapter was leaking, cracked or broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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
PALINDROME
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key10381493
MDR Text Key202510446
Report Number3009211636-2020-00184
Device Sequence Number1
Product Code MSD
UDI-Device Identifier10884521013148
UDI-Public10884521013148
Combination Product (y/n)N
PMA/PMN Number
K111372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Repair
Type of Report Initial,Followup,Followup
Report Date 10/07/2020
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 Model Number8888145014
Device Catalogue Number8888145014
Device Lot Number1715100153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Initial Date Manufacturer Received 07/22/2020
Initial Date FDA Received08/07/2020
Supplement Dates Manufacturer Received09/02/2020
09/21/2020
Supplement Dates FDA Received09/18/2020
10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
Patient Weight51
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