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

Model Number 8817749001

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

Event Description

According to the reporter, the patient had a semi-permanent catheter placed in the right neck and during the dialysis process, the doctor found a small amount of blood oozing from the catheter.They checked the catheter immediately and found that the venous luer adapter of the catheter was split (material fracture/break).Nothing unusual observed on the device prior to use.The product was flushed performed prior to use, the result was normal that the fittings were clean and it was flushed properly.The adapters were hand tighten.No other products being utilized with the device.No excessive force applied on the device.Saline was cleaning agent used on the device and it was typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.Tego was not utilized.They immediately given back blood to get off the machine, heparin sealing the tube, and the process went smoothly.The doctor who placed the catheter was contacted, and considered replacing the catheter tip at an optional time, and the patient was informed of the relevant precautions.The doctor replaced the catheter tip/adapter as intervention with the repair kit of the same product id (identifier) with different lot, the process went smoothly and the treatment was completed.No other intervention performed.There was unspecified amount of blood loss and blood transfusion was not required.There was no re ported patient injury.

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.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, due to uremia, the patient had a semi-permanent catheter placed in the right neck, and during the hemodia lysis process, the doctor found a small amount of blood oozing from the catheter.They checked the catheter immediately and found that the venous luer adapter of the catheter was split (a material fracture or break).Nothing unusual was observed on the device prior to use.The product was flushed prior to use, and the result was normal: the fittings were clean and it was flushed properly.The adapters were hand-tightened.No other products were being utilized with the device.No excessive force was applied to the device.Saline was the cleaning agent used on the device, and it was typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.Tego was not utilized.They immediately gave back blood to get off the machine, sealed the tube with heparin, and the process went smoothly.The doctor who placed the catheter was contacted and considered replacing the catheter tip at an optional time, and the patient was informed of the relevant precautions and that if there were special circumstances, patient could go to the hospital at any time.The doctor replaced the catheter tip or adapter as an intervention with the repair kit of the same product id (identifier) with a different lot a day after the event; the process went smoothly, and the treatment was completed.No other intervention was performed.There was an unspecified amount of blood loss, and a blood transfusion was not required.There was no reported patient injury.

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
• Type of Device: 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: 17195549
• MDR Text Key: 318131491
• Report Number: 3009211636-2023-00176
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 20884521009872
• UDI-Public: 20884521009872
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K871942
• 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
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8817749001
• Device Catalogue Number: 8817749001
• Device Lot Number: 2103600129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2023
• Date Device Manufactured: 05/24/2021
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 47 KG