MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERMCATH; CATHETER, SUBCLAVIAN

Model Number	8831692001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
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, at 15:30, the doctor was replacing the hemodialysis tube and accessories of the patient.Near the end of the operation, when preparing to connect the sterile infusion connector to the patient, it was discovered that one of the sterile infusion connectors was damaged.They immediately replaced with the spare disposable sterile infusion connector to complete the operation for the patient.The patient's p was 80 times/minute, r was 19 times/minute and bp (blood pressure) was 140/85mmhg.The patient did not complain of discomfort.There was no reported patient injury.
Event or Problem Description
According to the reporter, at 15:30, the doctor was replacing the hemodialysis tube and accessories of the patient.Near the end of the operation, when preparing to connect the luer adapter (sterile infusion connector) to the patient, it was discovered that one of the luer adapters was damaged.The venous/blue luer adapter had a crack and a leak was observed in the cracked area.The patient's pulse rate per minute was 80 times/minute, breath rate per minute was 19 times/minute and bp (blood pressure) was 140/85mmhg.The patient did not complain of discomfort.Tego was utilized and the catheter was repaired.There was no cleaning agent used on the device.Iodophor was the cleaning agent utilized to clean the adapters.The device was not replaced with a new product and the catheter was not explanted.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.There was nothing unusual observed on the device prior to use and there were no other products utilized with the device.A saline was used to flush the device prior to use and had no issues.They immediately replaced the luer adapter with a spare luer adapter or disposable sterile infusion connector to resolve the issue and complete the operation for the patient.Procedure was completed.There was blood loss of about 5ml and blood transfusion was not required.There was no intervention/medical treatment required as the result of the event.There were no current and pre-existing conditions of the patient that may be related to the event.There was no reported 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.

• Brand Name: PERMCATH
• Common Device Name: CATHETER, SUBCLAVIAN
• 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: 17980922
• Report Number: 3009211636-2023-00295
• Device Sequence Number: 2491938
• Product Code: LFJ
• UDI-Device Identifier: 10884521009882
• UDI-Public: 10884521009882
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: 06/13/2025
• Device Model Number: 8831692001
• Device Catalogue Number: 8831692001
• Device Lot Number: 2017500066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/10/2023
• Date Device Manufactured: 07/15/2020
• 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: 58 YR
• Patient Sex: Male