MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	8831661001
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter, the patient was planned to undergo bedside continuous renal replacement therapy (crrt) treatment intubation due to renal failure, and a double lumen venous catheter was placed at 15:30.At 16:00, bedside crrt treatment was performed, and at 17:00, continuous bleeding from the venous end of the double lumen catheter was found.Examination revealed a minimal crack in the venous end of the catheter.During crrt treatment hemorrhage was obvious, and the hemorrhage was temporarily reduced by the doctor after wrapping it with a transparent dressing.After that, the catheter was replaced for treatment.It was suspected that the central venous catheter had quality problems.There was nothing unusual observed on the device prior to use, and flushing was done prior to use with normal saline flushing.The cleaning agent used on the device was iodophor, the cleaning agent utilized to clean the adapters was iodophor, the cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area, there were no other products utilized with the device, and no excessive force was used on the device.Intervention/treatment was required as a result of the event.The procedure was completed.There was 50-80 ml of blood loss and blood transfusion was not required.No other abnormalities were found on the patient.There was no reported patient injury.
Event or Problem Description
According to the reporter, the patient was planned to undergo bedside continuous renal replacement therapy (crrt) treatment intubation due to renal failure, and a double lumen venous catheter was placed at 15:30.At 16:00, bedside crrt treatment was performed, and at 17:00, continuous bleeding from the venous end of the double lumen catheter was found.Examination revealed a minimal crack in the venous end of the catheter.During crrt treatment hemorrhage was obvious, and the hemorrhage was temporarily reduced by the doctor after wrapping it with a transparent dressing.After that, as an intervention the catheter was replaced for treatment.It was suspected that the central venous catheter had quality problems.There was nothing unusual observed on the device prior to use, and flushing was done prior to use with normal saline flushing.The cleaning agent used on the device was iodophor, the cleaning agent utili zed to clean the adapters was iodophor, the cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area, there were no other products utilized with the device, and no excessive force was used on the device.The procedure was completed.There was 50-80 ml of blood loss and blood transfusion was not required.No other abnormalities were found on the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b3, b5, g3 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.
Additional Manufacturer Narrative
Additional information: b5, g3 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 patient was planned to undergo bedside continuous renal replacement therapy (crrt) treatment intubation due to renal failure, and a double lumen venous catheter was placed at 15:30.At 16:00, bedside crrt treatment was performed, and at 17:00, continuous bleeding from the venous end (venous extension tube near the adapter) of the double lumen catheter was found.Examination revealed a minimal crack in the venous end (venous extension tube near the adapter) of the catheter.During crrt treatment hemorrhage was obvious, and the hemorrhage was temporarily reduced by the doctor after wrapping it with a transparent dressing.After that, as an intervention the catheter was replaced for treatment.It was suspected that the central venous catheter had quality problems.There was nothing unusual observed on the device prior to use, and flushing was done prior to use with normal saline flushing.The cleaning agent used on the device was iodophor, the cleaning agent utilized to clean the adapters was iodophor, the cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area, there were no other products utilized with the device, and no excessive force was used on the device.The clamp was not moved periodically.The procedure was completed.There was 50-80 ml of blood loss and blood transfusion was not required.No other abnormalities were found on the patient.There was no reported patient injury.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16143775
• Report Number: 3009211636-2023-00024
• Device Sequence Number: 5754093
• Product Code: FOZ
• UDI-Device Identifier: 10884521005235
• UDI-Public: 10884521005235
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K943349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2023

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 Model Number: 8831661001
• Device Catalogue Number: 8831661001
• Device Lot Number: 2123000117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 01/29/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 01/26/2023; 02/15/2023
• Date Device Manufactured: 01/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown