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

Model Number	8888135163
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the catheter insertion procedure began and when the procedure was carried out, the catheter's guide wire became entangled in the puncture needle.When withdrawing it, it was observed that the needle was defective and did not allow removal.A new catheter was required.The catheter was not repaired and there was no leak.There was no medical or surgical intervention needed to prevent a permanent impairment of a function and it did not lead to or extend patient hospitalization.The patient did not have any symptoms or complications associated with the event.There was no patient injury.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.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.
Event or Problem Description
According to the reporter, the catheter insertion procedure began and when the procedure was carried out, the catheter's guide wire became entangled in the puncture needle.When withdrawing it, it was observed that the needle was defective and did not allow removal.The catheter was not repaired and there was no leak.There was no cleaning agent used on the device and tego was not utilized.There was no luer adapter issue and cleaning on the insertion site was performed with surgical soap and surgical solution prior to product placement.There was nothing unusual observed on the device prior to use and there was no excessive force used to pull the product.The product was not rinsed before use and there were no other products being utilized with the device.There were no other defects/damages found on the product.There were no problems with the size of the catheter and there was no occlusion.The guide wire used and presented the issue was the one included in the kit.They tried to remove the guide wire first and when it was evident that the removal was difficult, a slight control was exercised that facilitated the exit of the guide wire and the subsequent removal of the catheter.There were no tools used when trying to remove the guide wire.The guide wire was still intact when it was removed (so there were no pieces retained in the patient).A new catheter was required and the procedure was completed.There was no blood loss.There was no medical or surgical intervention needed to prevent a permanent impairment of a function and it did not lead to or extend patient hospitalization.The patient did not have any symptoms or complications associated with the event.There was no patient injury.
Additional 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.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 11956986
• Report Number: 3009211636-2021-00133
• Device Sequence Number: 3565690
• Product Code: MPB
• UDI-Device Identifier: 10884521006386
• UDI-Public: 10884521006386
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K030209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2025
• Device Model Number: 8888135163
• Device Catalogue Number: 8888135163
• Device Lot Number: 2028300085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 08/24/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 08/26/2021; 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR