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

Model Number	8888135241
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the patient was transferred from the respiratory department due to end-stage renal disease, and the doctor inserted a right femoral vein hemodialysis catheter.After the catheter was placed, the patient went to the hemodialysis room for hemodialysis treatment and returned to the ward after the dialysis was completed.The next day, the accompanying staff reported to the nurse station that the temporary hemodialysis tube from the right femoral vein was removed by the patient.They immediately went to the bedside to check on the patient.The patient's hands were restrained with wristbands, and the temporary hemodialysis tube from the right femoral vein had completely come out from the securement wing, but the catheter was intact.The catheter fixing butterfly wings and sutures were still intact and fixed to the leg skin.The area around the puncture site was bruised purple with no active bleeding.When questioning the patient, the patient did not know that the hemodialysis tube had been removed.Flushing was performed before use, and there was no abnormality.Nothing unusual was observed on the device prior to use.No other defects or damages on the product.No other products were utilized with the device.Chlorhexidine acetate solution was used as the cleaning agent on the device.Vital signs were measured, the doctor was notified, and a new replacement hemodialysis catheter with the same lot and product id (identifier) was inserted in the patient on the next day of the event as the remedial action.The treatment was able to be continued and completed.They strengthened clinical publicity and anti-exubation education; patient restraint conditions were replaced with restraint gloves, reducing the chance of the patient's catheter being removed, and reporting suspicious consumables production process problems to the manufacturer.There was a small amount of blood seeped from the dressing, about 3 milliliters.Blood transfusion was not required.No medical intervention or treatment was required as a result of the event.There was no reported patient in jury.
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, the patient was transferred from the respiratory department due to end-stage renal disease, and the doctor inserted a right femoral vein hemodialysis catheter.After the catheter was placed, the patient went to the hemodialysis room for hemodialysis treatment and returned to the ward after the dialysis was completed.The next day, the accompanying staff reported to the nurse station that the temporary hemodialysis tube from the right femoral vein was removed by the patient.They immediately went to the bedside to check on the patient and noted that the patient's hands were restrained with wristbands even before the event occurred.They also noted that the temporary hemodialysis tube from the right femoral vein had completely come out from the securement wing, but the catheter was intact.The catheter fixing butterfly wings and sutures were still intact and fixed to the leg skin.The area around the puncture site was bruised purple with no active bleeding.When questioning the patient, the patient did not know that the hemodialysis tube had been removed.Flushing was performed before use, and there was no abnormality.Nothing unusual was observed on the device prior to use.No other defects or damages on the product.No other products were utilized with the device.Chlorhexidine acetate solution was used as the cleaning agent on the device.Vital signs were measured, the doctor was notified, and a new replacement hemodialysis catheter with the same lot and product id (identifier) was inserted in the patient on the next day of the event as the remedial action.The treatment was able to be continued and completed.They strengthened clinical publicity and anti-exubation education; patient restraint conditions were replaced with restraint gloves, reducing the chance of the patient's catheter being removed, and reporting suspicious consumables production process problems to the manufacturer.There was a small amount of blood seeped from the dressing, about 3 milliliters.Blood transfusion was not required.No medical intervention or treatment was required as a result of the event.There was no reported patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted one mahurkar catheter that was detached from its suture wing.There appeared to be no abnormalities with the device.It was reported that there was a securement wing issue.The reported issue was confirmed.The most likely cause could not be established from the information available.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: 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: 20665974
• Report Number: 1282497-2024-00523
• Device Sequence Number: 15511729
• Product Code: MPB
• UDI-Device Identifier: 10884521006539
• UDI-Public: 10884521006539
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2024

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: 8888135241
• Device Catalogue Number: 8888135241
• Device Lot Number: 2226500159
• 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: 10/27/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 12/05/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/21/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 62 KG