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

Model Number 8888145043CP

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

According to the reporter, the catheter's red or blue end had developed a split/crack (back ends).There was no available repair kit and the catheter remained in use.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.

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 arterial luer adapter (red) and venous luer adapter (blue) had developed a split/crack (back ends).It was stated that it was unknown when the crack occurred.The reported catheter was inserted on (b)(6)2022 and had been in placed for 5 months, 2 weeks and 4 days before cracks was noted.There was no leak and tego was not utilized.Clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes (ref: vjt638) was the cleaning agent used on the catheter and was also typically used to clean the adapters.There was nothing unusual documented at time of insertion and flushing was not documented at the time of insertion.All hemodialysis lines have the heparin lock withdrawn and lumen was flushed prior to every use and the adapter was tightened by hand.There were products utilized with the device: clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes (ref: vj t638), unisurge pack line on 3ml and 5ml syringes (ref: f810557), gambro artiset blood tubing system for hemodialysis with gambro artis (ref: 955549), unisurge pack line off 3ml and 5ml syringes, red uhs obturator cap (ref: f810558), bd plastipak 20ml luer-lok syringe (ref: 300629), bd vacutainer multiple sample luer adapter (ref: 367300), bd vacutainer one-use holder (catalogue number: 364815) and bd vacutainer blood collection tubes (ref: 363095).There was no excessive force used on the catheter.As a remedial action the manufacturer was contacted for advice on next steps, there were no repair kits available (out of stock), datix (safety report) was completed, quality and safety team of the hospital investigated.The dated photographs taken of both catheter lumens.New monitoring assessment tool was made to carryout daily assessment of lumens and catheter.The renal team researched different brand hemodialysis catheters to replace the catheters.All patients affected will need the catheter lines removed and replaced if appropriate due to the risk of infection and air embolus.There was no blood loss and blood transfusion was not required.There was no reported patient injury.

Event Description

According to the reporter, the catheter's arterial luer adapter (red) and venous luer adapter (blue) had developed a split/crack (back ends).It was stated that it was unknown when the crack occurred.The reported catheter was inserted on 01/02/2022 and had been in placed for 5 months, 2 weeks and 4 days before cracks was noted.There was no leak and tego was not utilized.Clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes (ref: vjt638) was the cleaning agent used on the catheter and was also typically used to clean the adapters.There was nothing unusual documented at time of insertion and flushing was not documented at the time of insertion.All hemodialysis lines have the heparin lock withdrawn and lumen was flushed prior to every use and the adapter was tightened by hand.There was no excessive force used on the catheter.There was no blood loss and blood transfusion was not required.There was no reported patient injury.

Manufacturer Narrative

Correction: 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.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• 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: 15113543
• MDR Text Key: 304797045
• Report Number: 3009211636-2022-00197
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158061
• UDI-Public: 10884521158061
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

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: 8888145043CP
• Device Catalogue Number: 8888145043CP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 08/25/2022; 11/07/2022
• Supplement Dates FDA Received: 09/09/2022; 12/02/2022
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 78 KG