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

Model Number	8888222220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use for arterial access for dialysis, patient was noted to be bleeding from the site of the dialysis catheter.Multiple interventions failed to stop the bleeding, it was stated that pressure was held for 30 minutes, thrombin was sprayed to the area, an unspecified amount of blood was lost and transfusion was done.Upon removal of the catheter, it was noted to be broken and had linear 1 centimeter tear just above the tip.It was not known when in the process the catheter broke and the catheter has only been in place less than 24 hours.It was reported that chlorhexidine/alcohol applicator was the cleaning agent used and a gluconate disk was used on the exit site, sorbaview shield was the dressing utilized.It was also stated that wound dressing did not include any antimicrobial properties, and they are allowed to dry thoroughly priot to dressing the area.The patient was not responsible for any type of catheter maintenance and the cleaning agents was not switched over the life of the catheter, sepsiderm was not used and no protocol changes was used in cleaning the device.The catheter was then removed and replaced.
Event or Problem Description
According to the reporter, during use for arterial access for dialysis, patient was noted to be bleeding from the site of the dialysis catheter (around the catheter).Multiple interventions failed to stop the bleeding, it was stated that pressure was held for 30 minutes, thrombin was sprayed to the area to stop bleeding, an unspecified amount of blood was lost and transfusion was done.Upon removal of the catheter, it was noted to be broken and had linear 1 centimeter tear just above the tip.It was not known when in the process the catheter broke and the catheter has only been in place less than 24 hours.It was reported that chlorhexidine/alcohol applicator was the cleaning agent used and a gluconate disk was used on the exit site, sorbaview shield was the dressing utilized.It was also stated that wound dressing did not include any antimicrobial properties, and they are allowed to dry thoroughly prior to dressing the area.The patient was not responsible for any type of catheter maintenance and the cleaning agents was not switched over the life of the catheter, sepsiderm was not used and no protocol changes was used in cleaning the device.The catheter was then removed and replaced with a new one to resolve the issue.
Additional Manufacturer Narrative
Additional info: b5, g4.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 ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9714836
• Report Number: 3009211636-2020-00046
• Device Sequence Number: 3381190
• Product Code: MPB
• UDI-Device Identifier: 10884521125841
• UDI-Public: 10884521125841
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888222220
• Device Catalogue Number: 8888222220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention