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

Model Number 8888541023

Device Problem Material Integrity Problem (2978)

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

Event Date 09/17/2020

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 dialysis treatment (around about two hours after connection at the dialyzer), it was said that a hair crack was observed on the blue luer adapter with blood leakage.The nurse saw it because the patient had a blood drop on her jacket (small blood drop, patient did not recognize that there were blood drops on her clothes).Nothing unusual observed aside from the reported issue.No other products being utilized with the device.Octenisept was the cleaning agent used on the device.The cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area.No instrument used to loosen or tighten the device as it was tighten by hands only.There was a blood loss of maximum of 50ml.No blood transfusion required.No medical intervention/treatment provided due to the event.Treatment was completed.It was said that the catheter was repaired.There was no reported 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 dialysis treatment (around about two hours after connection at the dialyzer), it was said that a very little hair crack was observed on the blue luer adapter with blood leakage.The nurse saw it because the patient had a blood drop on her jacket (small blood drop, patient did not recognize that there were blood drops on her clothes).Nothing unusual was observed aside from the reported issue.No other products were being utilized with the device.Octenisept was the cleaning agent used on the device and also used on cleaning the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area.No instrument was used to loosen or tighten the device as it was tightened by hands only.There was a blood loss of maximum of 50ml.No blood transfusion required.No medical intervention/treatment provided due to the event.Treatment was completed on the same day of the event.It was said that the catheter was repaired.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, d6a, d8, d9, g3, h3, h6, notified date : 2020-oct-14.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during dialysis treatment (around about two hours after connection at the dialyzer), it was said that a very little haircrack was observed on the blue luer adapter with blood leakage.The nurse saw it because the patient had a blood drop on her jacket (small blood drop, patient did not recognize that there were blood drops on her clothes).Nothing unusual observed aside from the reported issue.No other products being utilized with the device.Octenisept was the cleaning agent used on the device and also used on cleaning the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment(s) to the area.No instrument used to loosen or tighten the device as it was tighten by hands only.There was a blood loss of maximum of 50ml.No blood transfusion required.No medical intervention/treatment provided due to the event.Treatment was completed on the same day of the event.It was said that the catheter was repaired.There was no reported patient injury.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.Photos were available for evaluation.The returned device was a different device than the one pictured in the returned photos.Visual inspection noted that the arterial and venous luer adaptors were returned attached to the bifurcated y-hub.The cannula was detached.Close examination of the venous luer adaptor showed no evidence of the crack that was evident in the photos.It was reported that the luer adapter was cracked.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.

• 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: 10767274
• MDR Text Key: 214153624
• Report Number: 3009211636-2020-00267
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521135482
• UDI-Public: 10884521135482
• Combination Product (y/n): N
• PMA/PMN Number: K111817
• 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
• Report Date: 02/23/2021

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 Expiration Date: 04/30/2022
• Device Model Number: 8888541023
• Device Catalogue Number: 8888541023
• Device Lot Number: 1819000139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/31/2020
• Supplement Dates Manufacturer Received: 10/27/2020; 11/04/2020; 01/29/2021
• Supplement Dates FDA Received: 11/09/2020; 11/23/2020; 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 63