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

Model Number	8888135191
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
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, the patient was poisoned by drugs and needed emergency blood perfusion.After the doctor successfully placed the catheter, judged whether the blood flow was sufficient, there was a crack above the arterial end adapter and leaking blood.The catheter was removed immediately, replaced with a new one, it led to secondary intubation of the patient and the second product was inserted to complete the operation as preliminary action.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: a4, b5, d6a, d6b, e1 (first and last name), e3, 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, the patient was poisoned by drugs and needed emergency blood perfusion.After the doctor successfully placed the catheter, judged whether the blood flow was sufficient, there was a crack at the arterial extension tube above the adapter and leaking blood.No other defects/damages found on the product.No other products being utilized with the device.Nothing unusual observed on the device prior to use.No cleaning agent used on the device.The clamp was not moved periodically.Tego was not utilized.Flushing was not done.It led to secondary intubation of the patient which meant the catheter was removed immediately, replaced with a new one on the same day with the same product id (identifier) and lot, and re-inserted the second one to complete the operation as intervention.There was 10 milliliters of blood loss.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 patient was poisoned by drugs and needed emergency blood perfusion.After the doctor successfully placed the catheter, judged whether the blood flow was sufficient, there was a crack at the arterial extension tube above the adapter and leaking blood.No other defects/damages found on the product.No other products being utilized with the device.Nothing unusual observed on the device prior to use.No cleaning agent used on the device.The clamp was not moved periodically.Tego was not utilized.Flushing was not done.It led to secondary intubation of the patient which meant the catheter was removed immediately, replaced with a new one on the same day with the same product id (identifier) and lot, and re-inserted the second one to complete the operation as intervention and went for blood therapy.There was 10 milliliters of blood loss.Blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g3, 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.

• 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: 19735791
• Report Number: 1282497-2024-00208
• Device Sequence Number: 20926738
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2024

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: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 20230224
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 07/06/2024; 07/22/2024; 09/04/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 07/16/2024; 08/14/2024; 09/18/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG