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

Model Number	8888135131
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, after the patient was intubated and put on the machine, bleeding was found at the venous end.The product was replaced immediately and in time, and they checked the condition of the tubing carefully before catheter insertion as preliminary action.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, d6a, d6b, g3, h6 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, after the patient was intubated and put on the machine, bleeding was found at the venous extension tube.The catheter had been in place for one day.Nothing unusual was observed on the device prior to use.Flushing was done prior to use and had no abnormalities.They tighten the adapters by hand routinely.No other products were being utilized with the device.Tego was not utilized.Iodine disinfection was the cleaning agent used on the device.No other defects or damages were found on the product at the moment.They placed a catheter again as an intervention immediately and in time on the next day with the same product id (identifier), and they checked the condition of the tubing carefully before catheter insertion as a preliminary action, and the treatment was completed.There was no reported patient injury.
Event or Problem Description
According to the reporter, after the patient was intubated and put on the machine, bleeding was found at the venous extension tube.The catheter had been in place for one day.Nothing unusual was observed on the device prior to use.Flushing was done prior to use and had no abnormalities.They tighten the adapters by hand routinely.No other products were being utilized with the device.Tego was not utilized.Iodine disinfection was the cleaning agent used on the device, and it was the one typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.No other defects or damages were found on the product at the moment.They placed a catheter again as an intervention immediately and in time on the next day with the same product id (identifier), and they checked the condition of the tubing carefully before catheter insertion as a preliminary action, and the treatment was completed.There was a small amount of oozing blood.A blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: h6 (fdm).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, after the patient was intubated and put on the machine, bleeding was found at the venous upper end of extension tube.The catheter had been in place for one day.Nothing unusual was observed on the device prior to use.Flushing was done prior to use and had no abnormalities.They tighten the adapters by hand routinely.No other products were being utilized with the device.Tego was not utilized.Iodine disinfection was the cleaning agent used on the device, and it was the one typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.No other defects or damages were found on the product at the moment.They placed a catheter again as an intervention immediately and in time on the next day with the same product id (identifier), and they checked the condition of the tubing carefully before catheter insertion as a preliminary action, and the treatment was completed.There was a small amount of oozing blood.A blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (rfr).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, after the patient was intubated and put on the machine, bleeding was found at the venous upper end of extension tube which meant the venous extension tube near the adapter.The catheter had been in place for one day.Nothing unusual was observed on the device prior to use.Flushing was done prior to use and had no abnormalities.They tighten the adapters by hand routinely.No other products were being utilized with the device.Tego was not utilized.Iodine disinfection was the cleaning agent used on the device, and it was the one typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.No other defects or damages were found on the product at the moment.They placed a catheter again as an intervention immediately and in time on the next day with the same product id (identifier), and they checked the condition of the tubing carefully before catheter insertion as a preliminary action, and the treatment was completed.There was a small amount of oozing blood.A blood transfusion was not required.There was no reported patient injury.
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, after the patient was intubated and put on the machine, bleeding was found at the venous upper end of extension tube which meant the venous extension tube near the adapter.The catheter had been in place for one day.Nothing unusual was observed on the device prior to use.Flushing was done prior to use and had no abnormalities.They tighten the adapters by hand routinely.No other products were being utilized with the device.Tego was not utilized.Iodine disinfection was the cleaning agent used on the device, and it was the one typically utilized to clean the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.No other defects or damages were found on the product at the moment.They placed a catheter again as an intervention immediately and in time on the next day with the same product id (identifier) and same lot and they checked the condition of the tubing carefully before catheter insertion as a preliminary action, and the treatment was completed.There was a s mall amount of oozing blood.A 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: 19735812
• Report Number: 1282497-2024-00209
• Device Sequence Number: 12855980
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/02/2024

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 Model Number: 8888135131
• Device Catalogue Number: 8888135131
• Device Lot Number: 2320000116
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 08/29/2024; 09/17/2024; 10/09/2024; 11/25/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/23/2024; 09/09/2024; 09/30/2024; 10/18/2024; 12/02/2024
• Date Device Manufactured: 07/30/2023
• 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: 62 YR
• Patient Sex: Male