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

Model Number 8888145040

Device Problem Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, there was a leak and hair crack on the blue (venous) luer adapter.The catheter was repaired three months ago and tego was not utilized.Repair is no longer possible and catheter exchange was required.There was no patient injury.

Event Description

Event description: according to the reporter, during the dialysis treatment, the doctor found that there was a leak and hair crack found on the blue (venous) luer adapter and decided to switch to the single lumen treatment.It was stated that the catheter had already been repaired more than 6 months ago which was also due to leak and hair crack found the blue (venous) luer adapter.Flushing was not done before the treatment and no instrument was used to loosen or tighten the device.Octanisept was used to treat the insertion site prior to product placement and was also used as a cleaning agent on the device and the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.Extensions were utilized with the device which was placed 4 months ago.Tego was not utilized.There was no blood loss and blood transfusion was not required.There was no other intervention/treatment required as a result of event.Treatment was completed by using the intact part of the catheter.Repair was no longer possible for the current reported leak and hair crack and catheter exchange was required to resolve the issue.Re-implantation was done more than 2 weeks after the event.There was no patient injury.

Manufacturer Narrative

Additional information: a2, a3, a4, b3, d6, d7, udi, g4, pma / 510(k) #, h3, h6 correction: b5, d1, d2, d4(model number and catalog number) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.The first photo depicts the blue luer adapter with a crack down in the middle and the second photo depicts a close-up of the crack in the blue luer adapter.It was reported that the luer adapter was leaking, cracked and broken.The reported issue was 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.

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, during the dialysis treatment, the doctor found that there was a leak and hair crack found on the blue (venous) luer adapter and decided to switch to the single lumen treatment.It was stated that the catheter had already been repaired on (b)(6) 2020 (all repairs including the utilization of the extensions were done on this date) which was also due to leak and hair crack found on the blue (venous) luer adapter.Flushing was not done before the treatment and no instrument was used to loosen or tighten the device.Octanisept was used to treat the insertion site prior to product placement and was also used as a cleaning agent on the device and the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.Tego was not utilized.There was no blood loss and blood transfusion was not required.There was no other intervention/treatment required as a result of event.Treatment was completed by using the intact part of the catheter.Repair was no longer possible for the current reported leak and hair crack and catheter exchange was required to resolve the issue.Catheter explantation and re-implantation was performed on (b)(6) 2020.There was no patient injury.

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, during the dialysis treatment, the doctor found that there was a leak and hair crack found on the blue (venous) luer adapter and decided to switch to the single lumen treatment.It was stated that the catheter had already been repaired more than 6 months ago which was also due to leak and hair crack found the blue (venous) luer adapter.Flushing was not done before the treatment and no instrument was used to loosen or tighten the device.Octanisept was used to treat the insertion site prior to product placement and was also used as a cleaning agent on the device and the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.Extensions were utilized with the device which was placed 4 months ago.Tego was not utilized.There was no blood loss and blood transfusion was not required.There was no other intervention/treatment required as a result of event.Treatment was completed by using the intact part of the catheter.Repair was no longer possible for the current reported leak and hair crack and catheter exchange was required to resolve the issue.Catheter explantation and re-implantation was performed on (b)(6) 2020.There was no patient injury.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the blue adapter was received along with the red sealing cap.The blue luer adapter appeared intact with no signs of cracks.The extension tube was cut very close to the adapter.It was reported that the luer adapter was leaking, cracked or broken.The reported issue was 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.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: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10453533
• MDR Text Key: 204362627
• Report Number: 3009211636-2020-00198
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K111372
• 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: 01/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 8888145040
• Device Catalogue Number: 8888145040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 12/15/2020; 12/19/2020; 01/08/2021
• Supplement Dates FDA Received: 11/05/2020; 12/16/2020; 12/22/2020; 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 50