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

Model Number	8888145001
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
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 the day of the catheter insertion (post insertion), during a normal hemodialysis session, machine alarms activated and there was no blood flow.It was stated that the catheter was occluded on the catheter tip and may be due to a thrombosis.The customer tried to reverse the lines and the reverse flow was successful but only for some time.Again, the machine had the alarm.On the next day, the catheter was removed and replaced with the same brand (same lot).The new device was used successfully and the procedure was completed.It was noted that there was blood return prior to syringe flush and it was mentioned that the line was not hard to flush.This was not the infusion line.No anti-coagulant used.Flushing was done successfully prior to use.Nothing unusual observed on the device prior to use.No other products being utilized with the device.No other defects/damages found on the product.There was no problem with the catheter's dimension.The catheter was not repaired.There was no leak.Betadine was the cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.Povidone iodine and chlorhexidine were used to treat the insertion site prior to product placement.There was no blood loss.No other intervention/treatment required as a result of the event.There was no patient injury.
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, on the day of the catheter insertion (post insertion), during a normal hemodialysis session, machine (competitor's brand) alarms activated and there was no blood flow.It was stated that the catheter was occluded on the catheter tip and may be due to a thrombosis.The customer tried to reverse the lines and the reverse flow was successful but only for some time.Again, the machine had the alarm.On the next day, the catheter was removed and replaced with the same brand (same lot).The new device was used successfully and the procedure was completed.It was noted that there was blood return prior to syringe flush and it was mentioned that the line was not hard to flush.This was not the infusion line.No anti-coagulant used.Flushing was done successfully prior to use both to the catheter and replacement catheter.Nothing unusual observed on the device prior to use.No other products being utilized with the device.No other defects/damages found on the product.There was no problem with the catheter's dimension.The catheter was not repaired.There was no leak.Betadine was the cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.Povidone iodine and chlorhexidine were used to treat the insertion site prior to product placement.There was no blood loss.No other intervention/treatment required as a result of the event.There was no patient injury.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 12065581
• Report Number: 3009211636-2021-00149
• Device Sequence Number: 4752643
• Product Code: MSD
• UDI-Device Identifier: 10884521014084
• UDI-Public: 10884521014084
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 05/19/2025
• Device Model Number: 8888145001
• Device Catalogue Number: 8888145001
• Device Lot Number: 2014900167
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/18/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 58