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

Model Number 8888135191

Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506); Detachment of Device or Device Component (2907)

Patient Problems Blood Loss (2597); No Information (3190)

Event Date 07/18/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient had a temporary hemodialysis catheter implanted about a week ago, and the femoral vein was accessed, the patient was normal after implantation.Today, when the machine alarmed the nurse found the catheter unplugged and discarded on the bedside floor, the patient unplugged the catheter for unknown reasons.As a result, femoral vein bleeding occurred.The doctor performed hemostatic treatment and found that the pulled-out catheter was separated from the suture wings, and the suture wings were still well fixed by the suture on the skin of the patient.They stopped the dialysis and the patient was sent back after hemostatic treatment to re-insert the tube.Catheter was not repaired and there was no leak.Iodine was used to clean the device, tego was not utilized, there was no luer adapter issue.Insertion site was treated prior to product placement.There was no reported patient outcome.

Manufacturer Narrative

Additional information: b5, g4, 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.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, the patient had a temporary hemodialysis catheter implanted about a week ago, and the femoral vein was accessed, the patient was normal after implantation.Today, when the machine alarmed the nurse found the catheter unplugged and discarded on the bedside floor, the patient unplugged the catheter for unknown reasons.As a result, femoral vein bleeding occurred.The doctor performed hemostatic treatment and found that the pulled-out catheter was separated from the suture wings, and the suture wings were still well fixed by the suture on the skin of the patient.They stopped the dialysis and the patient was sent back after hemostatic treatment to re-insert the tube and to continue dialysis.Catheter was not repaired and there was no leak.Iodine was used to clean the device, tego was not utilized, there was no luer adapter issue.Insertion site was treated prior to product placement.It was reported that there was a blood loss of 50-100ml, and no blood transfusion was required.The patient's tube was replaced and continued dialysis.There was no reported patient outcome.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.Two photos were received for evaluation.Visual inspection noted the first image depicted a pool of blood on the floor and the second image showed a suture wing attached to a patient.It was reported that there was a securement wing and an ingrowth or catheter migration issue.The reported issues were confirmed.The most likely cause could not be established from the information available.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.

Event Description

According to the reporter, the patient had a temporary hemodialysis catheter implanted about a week ago, and the femoral vein was accessed, the patient was normal after implantation.Today, when the machine alarmed the nurse found the catheter unplugged and discarded on the bedside floor, the patient unplugged the catheter for unknown reasons.As a result, femoral vein bleeding occurred.The doctor performed hemostatic treatment and found that the pulled-out catheter was separated from the suture wings, and the suture wings were still well fixed by the suture on the skin of the patient.They stopped the dialysis and the patient was sent back after hemostatic treatment to re-insert the tube and to continue dialysis.Catheter was not repaired and there was no leak.Iodine was used to clean the device, tego was not utilized, there was no luer adapter issue.Insertion site was treated prior to product placement.It was reported that there was a blood loss of 50-100ml, and no blood transfusion was required.Patient's tube was replaced and continued dialysis.There was no reported patient outcome.

Event Description

According to the reporter, on (b)(6) 2020, the patient had a temporary hemodialysis catheter implanted, and the femoral vein was accessed; the patient was normal after implantation.On (b)(6), the patient underwent the third dialysis at the hemodialysis center.It was stated that the patient had a clear mind, and the answers were streamlined.He had no abnormal agitation and was sleeping after getting on the device.At 14:48, the patient raised his leg and scratched around the right groin while sleeping and accidentally pulled out the temporary hemodialysis tube in the right groin.The machine alarmed the nurse and found the catheter was unplugged and discarded on the bedside floor.As a result, femoral vein bleeding occurred.The nurse stepped forward to check and found that the arterial line was full of air bubbles and immediately stopped the pump.The doctor performed hemostatic treatment and found that the catheter was pulled-out (pressed immediately) and separated from the suture wings, and the suture wings were still well fixed by the suture on the skin of the patient's thigh.They stopped the dialysis, and the patient was sent back after hemostatic treatment to re-insert the tube and to continue dialysis.Nothing unusual was observed prior to use.No visible defects or damages found on the device.Catheter was not repaired, and there was no leak.Iodine was used to clean the device; tego was not utilized, and there was no luer adapter issue.Insertion site was treated prior to product placement.It was stated that they have reported to the doctor and re-punctured the blood vessel to give blood back and also assessed the patient's vital signs which were stable: the blood pressure was 137/63mmhg; heart rate was 67 beats/min;and, breathing was 19 beats/min.It was reported that there was a blood loss (femoral vein bleeding) of about 20ml, and no blood transfusion was required.It was noted that they communicated with the family members of patient.The intervention done was (the doctor stopped the bleeding, and sent the patient to the operating room to change the tube) patient's tube was explanted and replaced the same day and continued the dialysis.There was no reported patient outcome.

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 (b)(6) 2020, the patient had a temporary hemodialysis catheter implanted, and the femoral vein was accessed; the patient was normal after implantation.On (b)(6) the patient underwent the third dialysis at the hemodialysis center.It was stated that the patient had a clear mind, and the answers were streamlined.He had no abnormal agitation and was sleeping after getting on the device.At 14:48, the patient raised his leg and scratched around the right groin while sleeping and accidentally pulled out the temporary hemodialysis tube in the right groin.The machine alarmed the nurse and found out that the catheter was unplugged and discarded on the bedside floor.As a result, femoral vein bleeding occurred.The nurse stepped forward to check and found that the arterial line was full of air bubbles and immediately stopped the pump.The doctor performed hemostatic treatment and found that the catheter was pulled-out (pressed immediately) and separated from the suture wings.The suture wings were still well fixed by the suture on the skin of the patient's thigh.They stopped the dialysis and the patient was sent back after hemostatic treatment to re-insert the tube and to continue dialysis.Nothing unusual was observed prior to use.No visible defects or damages were found on the device.Catheter was not repaired, and there was no leak.Iodine was used to clean the device; tego was not utilized;and, there was no luer adapter issue.Insertion site was treated with iodine disinfection prior to product placement.It was stated that they have reported to the doctor and re-punctured the blood vessel to give blood back and also assessed the patient's vital signs which were stable, the blood pressure was 137/63mmhg, heart rate was 67 beats/min, breathing was 19 beats/min.It was reported that there was a blood loss(femoral vein bleeding) of about 20ml, and no blood transfusion was required.It was stated that the patient might feel painful, the skin might be torn, other was unspecified but no medical intervention and treatment provided.It was noted that they communicated with the family members of patient.The intervention done was (the doctor stopped the bleeding, and sent the patient to the operating room to change the tube) patient's tube was explanted and replaced with the catheter from another brand on the same day and continued the dialysis.There was no reported patient outcome.

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
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10388388
• MDR Text Key: 202510250
• Report Number: 3009211636-2020-00187
• 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,Followup,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 1831100158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1