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

Model Number 8888135191

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

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 Description

According to the reporter, on may 8, the patient needed femoral vein dialysis catheterization and crrt (continuous renal replacement therapy) treatment due to treatment requirement.The treatment continued until removal of the machine at 9:00 on may 11.It was said that when the blood was returned to the catheter, it was found that the catheter interface of the arterial end was damaged.It was noted that there was a blood leakage and liquid leakage.They reported the issue to the doctor immediately and performed extubation and then strengthened the observation of the disease.There was no reported patient outcome.

Manufacturer Narrative

Additional info: a5a, a5b, b5, d6b, g3, 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.

Event Description

According to the reporter, on (b)(6), the patient had a femoral vein dialysis catheterization and crrt (continuous renal replacement therapy) treatment due to treatment requirement.The treatment started on may 8 and continued until removal of the machine at 9:00 on (b)(6).It was said that when the blood was returned to the catheter, it was found that the catheter interface of the extension tube near the luer adapter had a crack and blood/liquid leakage occurred.Nothing unusual was observed on the device prior to treatment.There was no luer adapter issue.Tego was not utilized.No cleaning agent was used on the device.No cleaning agent was utilized to clean the adapters.No ointment was used.The clamps were not moved to a new location after each treatment.No other products were being utilized with the device.There was a blood loss of about 3ml and no blood transfusion was required.On that same day of the event, they reported the issue to the doctor immediately, performed extubation and had a new catheter replacement (same product identifier, unknown lot) which resolved the issue.It was said that the treatment was completed and they strengthened the observation of the disease.There was no reported patient injury.

Event Description

According to the reporter, on (b)(6), the patient had a femoral vein dialysis catheterization and crrt (continuous renal replacement therapy) treatment due to treatment requirement.The treatment started on (b)(6) and continued until removal of the machine at 9:00 on (b)(6).It was said that when the blood was returned to the catheter, it was found that the catheter interface of the extension tube near the luer adapter had a crack and blood/liquid leakage occurred.Nothing unusual was observed on the device prior to treatment.There was no luer adapter issue.Tego was not utilized.No cleaning agent was used on the device.No cleaning agent was utilized to clean the adapters.No ointment was used.The clamps were not moved to a new location after each treatment.No other products were being utilized with the device.There was a blood loss of about 3ml and no blood transfusion was required.On that same day of the event, they reported the issue to the doctor immediately, performed extubation and had a new catheter replacement (same product identifier, unknown lot) which resolved the issue.It was said that the treatment was completed and they strengthened the observation of the disease.There was no reported patient injury.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the luer adapter was found to be cracked, leaking, or broken.It was reported that there was a leak or hole on the extension tube at or near the luer adapter.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.The instructions included with this device provide the following guidance: clamping repeatedly on the same spot could weaken the tubing and clamping near the adapter and hub should be avoided.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
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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, CO 55112 ; 7635265677
• MDR Report Key: 14745141
• MDR Text Key: 302183479
• Report Number: 3009211636-2022-00152
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2022

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 Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2113300224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 06/14/2022; 10/20/2022
• Supplement Dates FDA Received: 06/27/2022; 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian