MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888135131
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, after catheterization, the catheter was dislodged from the fixation wing, causing catheter extubation.The fixed wings and the main part of the catheter fell off.There was no leak.Iodine was the cleaning agent used on the device.Tego was not utilized.There was no luer adapter issue.The insertion site was treated prior to product placement.The product was replaced with the same lot.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
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, right after implantation, the catheter was dislodged from the fixation wing, causing catheter extubation.The fixed wings and the main part of the catheter fell off.The catheter collar of the suture wing failed.The ring of the suture wing was not broken.The stitches hold.The catheter had been in place for 5 days.Nothing unusual was observed on the device prior to use.Flushing done prior to use.No other defects or damages were found on the product.Other products were being utilized with the device.There was no leak.Iodine was the cleaning agent used on the device.Tego was not utilized.There was no luer adapter issue.The insertion site was treated with routine iodine disinfection prior to product placement.The product was replaced with the same model product and same lot as remedial action, and they were able to proceed and complete the treatment.No medical intervention or treatment was required as a result of the event.There was no blood loss, and blood transfusion was not required.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.
Event or Problem Description
According to the reporter, the catheter was dislodged from the fixation wing, causing catheter extubation.The fixed wings and the main part of the catheter fell off.The catheter collar of the suture wing failed.The ring of the suture wing was not broken.The stitches hold.The catheter had been in place for 5 days.Nothing unusual was observed on the device prior to use.Flushing was done prior to use and had no abnormality.No other products being utilized with the device.No other defects or damages were found on the product.There was no leak.Iodine was the cleaning agent used on the device.Tego was not utilized.There was no luer adapter issue.The insertion site was treated with routine iodine disinfection prior to product placement.The product was replaced with the same model product and same lot as remedial action, and they were able to proceed and complete the treatment.No medical intervention or treatment was required as a result of the event.There was no blood loss, and blood transfusion was not required.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 suture wing was dislodged from the catheter.Functional testing found that the suture wing was cracked, broken, or detached from the catheter.It was reported that there was a securement wing issue.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.
Additional Manufacturer Narrative
Additional information: b5, 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, the catheter was dislodged from the fixation wing, causing catheter extubation.The fixed wings and the main part of the catheter fell off.The catheter collar of the suture wing failed.The ring of the suture wing was not broken.The stitches hold.The catheter had been in place for 5 days.Nothing unusual was observed on the device prior to use.Flushing was done prior to use and had no abnormality.No other products being utilized with the device.No other defects or damages were found on the product.There was no leak.Iodine was the cleaning agent used on the device.Tego was not utilized.There was no luer adapter issue.The insertion site was treated with routine iodine disinfection prior to product placement.The product was replaced with the same model product and same lot on the same day as remedial action, and they were able to proceed and complete the treatment.No medical intervention or treatment was required as a result of the event.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: 20506797
• Report Number: 1282497-2024-00450
• Device Sequence Number: 8209934
• Product Code: MPB
• UDI-Device Identifier: 10884521006201
• UDI-Public: 10884521006201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/08/2025

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 Model Number: 8888135131
• Device Catalogue Number: 8888135131
• Device Lot Number: 2335200145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/11/2024; 11/25/2024; 12/17/2024; 01/02/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/14/2024; 12/02/2024; 12/23/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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