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

Model Number	8888145043CP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem Description
According to the reporter, the catheter's venous and arterial end of the luer adapter (both lumens) developed split/cracks (inserted on (b)(6) 2018).The issue was first documented on (b)(6) 2022 on venous (blue) lumen and (b)(6) 2022 on arterial (red) lumen.There was no leak.Tego was not utilized.Luer adapters were usually tightened by hand.The cleaning agents used were clinell 2% and chlorhexidine in 70% alcohol individually wrapped wipes (ref.Vjt638) and it was also mentioned as products utlized with the device.There was nothing unusual observed on the device at the time of insertion.It was mentioned flushing was not documented at time of insertion.All hemodialysis lines had heparin lock withdrawn and lumens were flushed prior to every use.The products utilized with the device were unsurge pack line on 3ml and 5ml syringes (ref.F810557 ), gambro artiset blood tubing system for hemodialysis with gambro artis (ref.955549), unsurge pack line off 3ml and 5ml syringes and red uhs obturator cap (ref.F810558), bd plastipak 20ml luer lock syringe (ref.300629), bd vacutainer multiple sample luer adapter (ref.367300), "bs vacutainer one-use holder" catalogue number: 3 64815 and bd vacutainer blood collection tubes (ref: 363095).No excessive force used on the catheter.The company 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 jersey general hospital was investigating, dated photographs were taken of both catheter lumens, new monitoring assessment tool made to carryout daily assessment of lumens and catheter.Renal team researching different brand hemodialysis catheters to replace catheters.The patient needed to remove and replace the catheter 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.
Additional Manufacturer Narrative
Additional information: a2, a3, a4, b5, d1, d2, d4(model#, catalog#, lot#, udi#), d6a, d8, g1, g3, g4, h6 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.
Additional Manufacturer Narrative
Additional information: d6a, g3, h6 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
• Common Device Name: 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, CO 55112 ; 7635265677
• MDR Report Key: 15113077
• Report Number: 3009211636-2022-00192
• Device Sequence Number: 14890065
• Product Code: NYU
• UDI-Device Identifier: 10884521158061
• UDI-Public: 10884521158061
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888145043CP
• Device Catalogue Number: 8888145043CP
• Device Lot Number: 1710100106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 11/21/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 09/10/2022; 12/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 86 KG