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)
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.
Additional Manufacturer Narrative
Additional information: a2, a3, a4(weight in lbs), b5, d1, d2, d4(model #, catalog #, expiration date, lot # and unique identifier (udi) #), d6a, e1(facility name, street 1, city and postal code) e3, g1(manufacturer name, mfr contact first name, last name, street 2, mfr city, region, postal code, email and phone number), g2, g3, pma / 510(k) #, h6 correction: d8 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 was inserted on (b)(6) 2022 (6 months and 5 days before cracks noted), the venous (blue) lumen was documented to had split/crack (back ends) on (b)(6) 2022 and the arterial (red) lumen on (b)(6), 2022.There was no leak and tego was not utilized.Clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes were the cleaning agent typically used on the device specifically to clean the adapters.Hand was utilized to tighten the adapters and there was no excessive force used on catheter.There was no blood loss and blood transfusion was not required.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 flushed prior to every use.Clinell 2% chlorhexidine in 70% alcohol individually wrapped wipes, unisurge pack line on 3ml and 5ml syringes, gambro artiset blood tubing system for hemodialysis with gambro artis, unisurge pack line off 3ml and 5ml syringes and red uhs obturator cap, bd plastipak 20ml luer-lok syringe, bd vacutainer multiple sample luer adapter, bd vacutainer one-use holder catalogue number: 364815, bd vacutainer blood collection tubes were the products being utilized with the device.Manufacturer was contacted for advice on next steps, no repair kits available (out of stock), datix (safety report) completed, quality and safety team of the hospital investigated.Dated photographs taken of both catheter lumens, new monitoring assessment tool made to carryout daily assessment of lumens and catheter.The renal team researched different brand hemodialysis catheters to replace the catheters.All affected will need the lines removed and replaced if appropriate due to the risk of infection and air embolus.There was no blood loss.There was no patient injury.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 15026838
• Report Number: 3009211636-2022-00171
• Device Sequence Number: 6123705
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022
• 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 Expiration Date: 04/01/2024
• Device Model Number: 8888145043CP
• Device Catalogue Number: 8888145043CP
• Device Lot Number: 2026000166
• 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: 06/25/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 09/12/2022
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 88 KG