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.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 catheter's blue hub was cracked.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, after dialysis treatment, it was observed that the catheter's blue luer adapter had a crack.It was stated that the catheter had been in place for five months at the time of the event.There was a leak at the blue luer adapter.There was nothing unusual observed on the device prior to use.Flushing was done prior to use with good flow result.Besides the reported issue, there was no other visible defects/damages found on the product at the time of the event.Tego was utilized.The cleaning agent typically utilized to clean the catheter in its entirety was alcohol 70%.The clamps were not moved to a new location after each treatment.The cleaning agents were not switched over the life of the catheter, the cleaning agents were not mixed, no protocol change for the cleaning agents used recently, and the patients themselves were not using any type of cleaning agent or antibiotic on the catheters.There were no ointments utilized at the exit site, the wound dressing utilized was iv dressing pad, the wound dressing did not include any cleaning agents or antimicrobial properties, the cleaning agent was not allowed to dry thoroughly prior to dressing the area, the patient was not responsible for any type of catheter maintenance, and sepsiderm was not used to clean the catheters.There were no other products utilized with the device.No excessive force was used on the device.It was stated that as a remedial action the reported product was explanted, and a new catheter was inserted.There was no blood loss and blood transfusion was not required.There was no reported patient injury.

Event Description

According to the reporter, after dialysis treatment, it was observed that the catheter's blue luer adapter had a crack.There was a leak at the blue luer adapter.It was stated that the catheter has been in place for five months at the time of the event.There was nothing unusual observed on the device prior to use.Flushing was done prior to use with good flow result.Besides the reported issue there was no other visible defects/damages found on the product at the time of the event.Tego was utilized.The cleaning agent typically utilized to clean the catheter in its entirety was alcohol 70%.The cleaning agent typically utilized to clean the adapters was chlorhexidine 1:200 in alcohol 70% 60ml.The cleaning agents were not switched over the life of the catheter, the cleaning agents were not mixed, no protocol change for the cleaning agents used recently, and the patients themselves are not using any type of cleaning agent or antibiotic on the catheters.There were no ointments used/utilized at the exit site, the wound dressing utilized was iv dressing pad, the wound dressing did not include any cleaning agents or antimicrobial properties, the cleaning agent were not allowed to dry thoroughly prior to dressing the area, the patient was not responsible for any type of catheter maintenance, and sepsiderm was not used to clean the catheters.Lotions were not used.The clamps were not moved to a new location after each treatment.The adapters were tightened by hand.There were no other products utilized with the device.No excessive force was used on the device.It was stated that as a remedial action the reported product was explanted, and a new catheter was inserted.There was no blood loss and blood transfusion was not required.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, g3 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

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the venous luer adapter had a crack in it.Given that the device was in use for several months, it can be assumed that the crack was not present when the device was implanted.It was reported that the luer adapter was leaking, cracked or broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: 17321567
• MDR Text Key: 319012568
• Report Number: 1000312731-2023-00001
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521013169
• UDI-Public: 20884521013169
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• 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: 2124500123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female