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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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COVIDIEN LLC MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number 8888135241
Device Problems Product Quality Problem (1506); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2024
Event Type  malfunction  
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 Description
According to the reporter, during use, the whole part of the fixed wing fell off.The thread was fixed and the head came off.The catheter was not repaired.There was no leak and there was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.There was nothing unusual observed on the device prior to use.No other defects damages found on the product.There were no other products utilized with the device.Flushing was done prior to use.The ring of the suture wing was not broken.There was no remedial action done to resolve the issue and procedure was completed.There was no blood loss and blood transfusion was not required.There was no intervention medical treatment required as the result of the event.There was no reported patient injury.
 
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 Description
According to the reporter, during use, the whole part of the fixed wing fell off.The thread was fixed and the head came off.It was mentioned that the surgical catheter was found to have fallen off during the wearing process, not when the machine was used for treatment.The catheter was not repaired.There was no leak and there was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.There was nothing unusual observed on the device prior to use.No other other defects/damages found on the product.There were no other products utilized with the device.Flushing was done prior to use and had a normal result.The ring of the suture wing was not broken.There was no remedial action done to resolve the issue and procedure was completed.The event did not occur during dialysis.There was no blood loss and blood transfusion was not required.There was no intervention/medical treatment required as the result of the event.There was no reported patient injury.
 
Manufacturer Narrative
Additional information: h6 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 Description
According to the reporter, during use, the whole part of the fixed wing fell off.The thread was fixed and the head came off.It was mentioned that the surgical catheter was found to have fallen off during the wearing process (the whole part of the fixed wing fell off), not when the machine was used for treatment.The catheter was not repaired.There was no leak and there was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.There was nothing unusual observed on the device prior to use.No other other defects/damages found on the product.There were no other products utilized with the device.Flushing was done prior to use and had a normal result.The ring of the suture wing was not broken.There was no remedial action done to resolve the issue and procedure was completed.The event did not occur during dialysis.There was no blood loss and blood transfusion was not required.There was no intervention/medical treatment required as the result of the event.There was no reported patient injury.
 
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Brand Name
MAHURKAR
Type of Device
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 Key18956465
MDR Text Key338948399
Report Number3009211636-2024-00083
Device Sequence Number1
Product Code MPB
UDI-Device Identifier10884521006539
UDI-Public10884521006539
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K192302
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/02/2024
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
Device Operator Health Professional
Device Model Number8888135241
Device Catalogue Number8888135241
Device Lot Number2307900159
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/28/2024
Initial Date FDA Received03/21/2024
Supplement Dates Manufacturer Received03/13/2024
04/09/2024
Supplement Dates FDA Received04/08/2024
05/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age75 YR
Patient SexMale
Patient Weight62 KG
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