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

Model Number	8888145048
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, four months after catheter insertion, leakage was noted at the junction of the extension tube and bifurcate.The catheter was not repaired.Tego was not utilized.There was no luer adapter issue.There was no patient injury.
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, four months after catheter insertion, before the initiation of dialysis treatment, leakage was noted at the junction of the extension tube and bifurcate.A catheter exchange was scheduled urgently to resolve the issue.There was no blood loss.Blood stain was noticed when accessing the catheter.Blood transfusion was not required.There was no treatment due to the leakage and hd (hemodialysis) until the catheter was changed.The catheter was not repaired.Tego was not utilized.There was no luer adapter issue.Betadine and chloraprep were used as cleaning agents and no other topical agents were used for the catheter.No ointment utilized at the exit site.Chlorhexidine impregnated dressing was used as wound dressing and it included cleaning agents or antimicrobial properties.The cleaning agents were allowed to dry thoroughly prior to dressing the area.The patient was not responsible for any type of catheter maintenance.The cleaning agents never switched over the life of the catheter and never mixed.The site n ever used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheter.The catheter was mainly used for hemodialysis only.They used transparent dressing, hypafix, and statlock (dialysis) to hold the catheter in the patient.There was no patient injury.
Additional 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.
Event or Problem Description
According to the reporter, four months after insertion of the chronic dialysis catheter, before the initiation of dialysis treatment, leakage was noted at the junction of the venous port/extension tube and bifurcate where a crack observed.There was unspecified amount of blood loss and blood transfusion was not required.There was no treatment due to the leakage and hd (hemodialysis) until the catheter to be changed.A catheter exchange was scheduled urgently to resolve the issue, the new device was used successfully, and the procedure was completed.It was stated that the clamps were not moved to a new location after treatment.The catheter was not repaired.Tego was not utilized.There was no luer adapter issue.Betadine and chloraprep were used as cleaning agents and no other topical agents were used for the catheter.No ointment utilized at the exit site.Chlorhexidine impregnated dressing was used as wound dressing and it included cleaning agents or antimicrobial properties.The cleaning agents were allowed to dry thoroughly prior to dressing the area.The patient was not responsible for any type of catheter maintenance.The cleaning agents never switched over the life of the catheter and never mixed.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheter.The catheter was mainly used for hemodialysis only.They used transparent dressing, hypafix, and statlock (dialysis) to hold the catheter in the patient.Flushing was not done prior to use.There was no patient injury.

• Brand Name: PALINDROME
• Common Device Name: 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11826833
• Report Number: 3009211636-2021-00107
• Device Sequence Number: 14456848
• Product Code: MSD
• UDI-Device Identifier: 10884521013278
• UDI-Public: 10884521013278
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2021
• Device Model Number: 8888145048
• Device Catalogue Number: 8888145048
• Device Lot Number: 1831600237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/25/2021; 12/14/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/15/2021; 01/03/2022
• Date Device Manufactured: 12/19/2018
• 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 Sex: Male