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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, IMPLANTED
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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Model Number 8888145001
Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the patient was given an indwelling central venous catheter set to establish a vascular access for hemodialysis treatment for a long period of time as the patient was unable to establish an arteriovenous internal fistula.During the surgery, venous leakage was found at the venous end.It was mentioned that there was no combined medication/device.The catheter was replaced immediately.
 
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 Description
According to the reporter, the patient was given an indwelling central venous catheter set to establish a vascular access for hemodialysis treatment for a long period of time as the patient was unable to establish an arteriovenous internal fistula.During the surgery, venous leakage was found at the venous end (at the closed clip of the transparent epitaxial tube connected to the jointer, near the adapter).There was no combined medication/device.The catheter was not repaired, and there was no cleaning agent used on the device and on the adapters.Tego was not utilized, and there was no luer adapter issue.Disinfection using aner iodine was performed on the insertion site prior to product placement.The clamp was not moved periodically, and normal slight rotation was utilized to tighten the adapters.There was no ointment used or applied to the area.There was no damage to the device's box and packaging.There was nothing unusual observed on the device prior to use.Flushing was done, but it was not known whether the tube was leaking.There were no other products being utilized with the device.It was not checked carefully whether there were other defects/damages found on the product.Blood transfusion was not required, and there was no intervention/treatment required as a result of the event.The catheter was replaced immediately, and the procedure was completed.There was no patient injury.
 
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Brand Name
MAHURKAR
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
CS  20101
MDR Report Key10933857
MDR Text Key219173883
Report Number3009211636-2020-00293
Device Sequence Number1
Product Code MSD
UDI-Device Identifier10884521014084
UDI-Public10884521014084
Combination Product (y/n)N
PMA/PMN Number
K111372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 01/08/2021
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
Device Operator Health Professional
Device Expiration Date10/09/2023
Device Model Number8888145001
Device Catalogue Number8888145001
Device Lot Number1831000103
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/10/2020
Initial Date FDA Received12/02/2020
Supplement Dates Manufacturer Received12/14/2020
Supplement Dates FDA Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
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