MAUDE Adverse Event Report: COVIDIEN LLC PERMCATH; CATHETER, SUBCLAVIAN

Model Number	8817748001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during use, the catheter has three holes in the body.There was a leak on the catheter shaft.There was no cleaning agent used on the device.Dilga was not used.There was no problem with luer adapter.No disinfectant used to disinfect catheter.No wound dressing had been used.Sepsiderm to clean the catheter was not used.No protocol changed for cleaning agents used recently.Nothing unusual observe on the device.Flushing was done prior to use and no abnormalities were found.No other defects/damages found on the product.No other products being utilized with the device.No excessive force used on the device.As a remedial action the surgeon replaced it on the spot with a new catheter for the patient.The insertion site was not treated prior to product placement.There was no blood loss and blood transfusion was not required due to the event.No intervention/treatment required due to the reported product.There was no reported patient injury.
Event or Problem Description
According to the reporter, during use, the catheter had three holes in the body.There was a leak on the catheter shaft.There was no cleaning agent used on the device.Tego was not used.There was no problem with luer adapter.No disinfectant was used to disinfect the catheter.No wound dressing had been used.Sepsiderm to clean the catheter was not used.No protocol was changed for cleaning agents used recently.There was nothing unusual observed on the device.Flushing was done prior to use, and no abnormalities were found.No other defects or damages were found on the product.No other products were being utilized with the device.No excessive force was used on the device.As a remedial action, the surgeon replaced it on the spot with a new catheter for the patient.The insertion site was not treated prior to product placement.There was no blood loss, and a blood transfusion was not required due to the ev ent.No intervention or treatment was required due to the reported product.There was no reported patient injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: b5 additional information: g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during use, the catheter had three holes in the body.There was a leak on the catheter shaft.There was no cleaning agent used on the device.Tego was not used.There was no problem with luer adapter.No disinfectant was used to disinfect the catheter.No wound dressing had been used.Sepsiderm to clean the catheter was not used.No protocol was changed for cleaning agents used recently.There was nothing unusual to observe on the device.Flushing was done prior to use, and no abnormalities werefound.No other defects or damages were found on the product.No other products were being utilized with the device.No excessive force was used on the device.As a remedial action, the surgeon replaced it on the spot with a new catheter for the patient.The insertion site was not treated prior to product placement.There was no blood loss, and a blood transfusion was not required due to the e vent.No intervention or treatment was required due to the reported product.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the cannula was found to have a leak.It was reported that there was a leak on the catheter shaft.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PERMCATH
• Common Device Name: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19813152
• Report Number: 1282497-2024-00227
• Device Sequence Number: 8891063
• Product Code: LFJ
• UDI-Device Identifier: 10884521009868
• UDI-Public: 10884521009868
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/09/2024

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: 03/10/2026
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 2103600122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/09/2024; 08/12/2024; 10/08/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/11/2024; 08/13/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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: Prefer Not To Disclose