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

Model Number 8888135191

Device Problem Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 05/19/2020

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, it was stated that the patient had edema and had been treated with crrt (continuous renal replacement therapies) for 90 days.Hematoma had appeared after extubation and tube could not be placed, they said crrt treatment can only stop for one day, the patient's edema worsened the next day.They said that the catheter was placed on the same day, the treatment was for one hour, and the tube was replaced after discovery, the clamp was opened during treatment, and close after treatment.It was mentioned that sterile disinfection was done on the insertion site (femoral vein) prior to product placement.Flushing was done prior to use and the result was normal, there was nothing unusual and there was no damage noted on the device prior to use, catheter was not repaired, leak was noted at the junction of the extension tube and bifurcation, sterile disinfection was done with saline and alcohol was used to clean the device.Tego was not utilized and there was no problem with the luer connector.There was eventual blood loss of up to 30 ml, blood transfusion was not required.They replaced the catheter of another brand.Patient forced to stop crrt treatment for one day due to the event.There was no reported patient outcome.The patient continues to do the crrt treatment every and his condition was stable.

Manufacturer Narrative

Additional information: b5, g4.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, during use, it was stated that the patient had edema and had been treated with crrt (continuous renal replacement therapies) for 90 days.Hematoma had appeared after extubation and tube could not be placed, they said crrt treatment can only stop for one day, the patient's edema worsened the next day.According to the patient's situation, the catheter will be replaced 5-7 days.They said that the catheter was implanted on the same day (the catheter was implanted 4 days after it was removed), and after an hour of re-implanted new catheter treatment, blood leakage was found and treatment was stopped.The clamp was opened during treatment, and close after treatment.It was mentioned that sterile disinfection was done on the insertion site (femoral vein) prior to product placement.Flushing was done prior to use and the result was normal, there was nothing unusual and there was no damage noted on the device prior to use, catheter was not repaired, leak was noted at the junction of the extension tube and bifurcation, sterile disinfection was done with saline and alcohol was used to clean the device.Tego was not utilized and there was no problem with the luer connector.There was eventual blood loss of up to 30 ml, blood transfusion was not required.They replaced the catheter of another brand.Patient forced to stop crrt treatment for one day due to the event.There was no reported patient outcome.The patient continues to do the crrt treatment every and his condition was stable.

Manufacturer Narrative

Additional information: a4, d10, g4, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional evaluation found that there was a hole in the extension tube which led to a leak.It was reported that there was a leak or hole on the extension tube.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This can occur when mishandled during clinical application.The manufacturing records for each device are also 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.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10121026
• MDR Text Key: 194062280
• Report Number: 3009211636-2020-00106
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2020

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 Date: 05/08/2024
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 1914800170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 06/03/2020; 07/21/2020
• Supplement Dates FDA Received: 06/19/2020; 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 70