MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888135131
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on (b)(6) 2021, the patient underwent aseptic operation of the right internal jugular vein temporary dialysis catheterization, followed by regular hemodialysis treatment.On (b)(6) 2021, the patient was undergoing routine hemodialysis in the hemodialysis room, when the nurse opened the dressing at the temporary catheterization of the right internal jugular vein, a crack and leak was found in the venous end tube (pipeline was damaged).Immediately clamped the venous access and notified the doctor.The damaged catheter was removed and replaced with the new temporary dialysis tube in the neck.There was no blood loss and no blood transfusion required.After replacement, the patient completed the dialysis treatment.Flushing was done prior to use and was unobstructed.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.The clamps were moved to a new location after each treatment.There were other products being utilized with the device.There was no patient injury.
Additional Manufacturer Narrative
H3: 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 a catheter with a close up on the tubing of the venous luer adaptor.The tubing had a cut in it which was leaking.It was reported that there was a leak or hole on the extension tube.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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12473910
• Report Number: 3009211636-2021-00252
• Device Sequence Number: 11946779
• Product Code: MPB
• UDI-Device Identifier: 10884521006201
• UDI-Public: 10884521006201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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: 08/14/2023
• Device Model Number: 8888135131
• Device Catalogue Number: 8888135131
• Device Lot Number: 1825400153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2018
• 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: 74 YR
• Patient Sex: Female