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

Model Number 8888145015

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

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.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 patient use, there was a dysfunction of the machine's sensors, which was why the patient was returned, lines were washed, the cassette was installed in a new machine and the patient was connected again.Asepsis was observed with 0.2% chlorhexidine cloths.At the lumen of the catheter, tego was in good condition however when removing the tego, a fissure (crack) was observed at the point of attachment in the venous side (luer adapter).There were no other deficient products used during the event.The catheter was not repaired.There was no leak.The insertion site was not treated prior to product placement.Permeability was checked with arterial return and venous return.The doctor who requested support from medical direction had to define behavior.The doctor asked safety questions to the patient, it was considered to continue therapy only for the day with the connection reversed after only 3 hours of treatment with low qb (blood flow rate).The patient was informed of the condition of access and urgent catheter change was ordered for (b)(6)2023.Patient required a medical intervention (surgery) to change the product.There was no reported patient injury.

Manufacturer Narrative

Additional information: (street 1, street 2, region).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, 55 days after implanted, during patient use, there was a dysfunction of the machine's sensors, which was why the patient was returned, lines were washed, the cassette was installed in a new machine and the patient was connected again.Asepsis was observed with 0.2% chlorhexidine cloths.At the lumen of the catheter, tego was in good condition however when removing the tego, a fissure (crack) was observed at the point of attachment in the venous side (luer adapter).There were no other deficient products used during the event.The catheter was not repaired.There was no leak.The insertion site was not treated prior to product placement.Isopañin plus 2% was cleaning agent used on the device.2% chlorhexidine gluconate and 70% isopropyl alcohol were the cleaning agents typically used to clean the adapters.The cleaning agents were allowed to dry thoroughly prior to applying ointment to the area.Flushing was done prior to use, washing with saline solution were performed and during the previous therapies, they did not present complications.Nothing unusual observed on the device prior to use.No excessive force applied on the device.The method utilized to tighten the adapters was by hand.Permeability was checked with arterial return and venous return.The doctor who requested support from medical direction had to define behavior.The doctor asked safety questions to the patient, it was considered to continue therapy only for the day with the connection reversed after only 3 hours of treatment with low qb (blood flow rate).The reverse flow was successful and the 3 hours ordered by nephrology was completed.The patient was informed of the condition of access and urgent catheter change was ordered for (b)(6) 2023.Patient required a medical intervention (surgery) to change the product.There was no blood loss and blood transfusion was not required.There was no reported patient injury.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted a crack in the venous luer adapter.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 ; 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 55112 ; 7635265677
• MDR Report Key: 17022516
• MDR Text Key: 316148358
• Report Number: 3009211636-2023-00156
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521013169
• UDI-Public: 20884521013169
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2023

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: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 2203200073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 06/01/2023; 08/10/2023
• Supplement Dates FDA Received: 06/16/2023; 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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: 59 YR
• Patient Sex: Male