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U.S. Department of Health and Human Services

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

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number 8888135241
Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, for crrt (continuous renal replacement therapies) treatment, patient underwent catheterization of the right femoral vein 2 days ago.The catheter was inserted smoothly.Flushing was done prior to use and there was no leakage found.When measuring the flow with the syringe, it was found that the venous end (blue) silicone epitaxial tube and the blue joint overlapped with a gap of about 2mm.When the syringe was aspirated, a very small amount of blood leaked out (not more than 1 ml), blood transfusion was said not required.The doctor immediately extubated the catheter and placed another product of the same model.It was mentioned that there were no defects/damages noted on the device prior to use, and there was no damage tear/dent noted on both internal/external package of the product.The product was sealed upon receipt.Catheter was not repaired.Cracks observed in the blue luer connector.Iodophor was the cleaning agent utilized to clean the adapters.There was no method utilized to tighten the adapters.Tools was not used to loosen or tighten the instruments.There were no any products being utilized with the device.There were no any patient symptoms or complication related to the event.The crrt operation went smoothly.The treatment was completed.There was no reported patient injury.
 
Event Description
According to the reporter, for crrt (continuous renal replacement therapies) treatment, patient underwent catheterization of the right femoral vein two days ago.The catheter was inserted smoothly.Flushing was done prior to use and there was no leakage found.When measuring the flow with the syringe, it was found that the venous end (blue) silicone epitaxial tube and the blue joint overlapped with a gap of about 2mm.When the syringe was aspirated, a very small amount of blood leaked out (not more than 1 ml); leak was found in the extension tube.Blood transfusion was not required.The doctor immediately extubated the catheter and placed another product of the same model.It was mentioned that there were no defects/damages noted on the device prior to use, and there was no damage tear/dent noted on both internal/external package of the product.The product was sealed upon receipt.Catheter was not repaired.Cracks were observed in the blue luer connector.Iodophor was the cleaning agent utilized to clean the adapters.There was no method utilized to tighten the adapters.Tools were not used to loosen or tighten the instruments.There were no any products being utilized with the device.There were no any patient symptoms or complications related to the event.The crrt operation went smoothly.The treatment was completed.There was no reported patient injury.
 
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 of the first image showed a hole at the junction of the blue luer adapter and extension tube; the second image showed a different angle view of the hole at the junction of the blue luer adapter and extension tube, and there was a red circle drawn around the hole.It was reported that the luer adapter was cracked.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.
 
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, for crrt (continuous renal replacement therapies) treatment, patient underwent catheterization of the right femoral vein 2 days ago.The catheter was inserted smoothly.Flushing was done prior to use and there was no leakage found.When measuring the flow with the syringe, it was found that the venous end (blue) silicone epitaxial tube and the blue joint overlapped with a gap of about 2mm.When the syringe was aspirated, a very small amount of blood leaked out (not more than 1 ml), leak was found in the extension tube, blood transfusion was said not required.The doctor immediately extubated the catheter and placed another product of the same model.It was mentioned that there were no defects/damages noted on the device prior to use, and there was no damage tear/dent noted on both internal/external package of the product.The product was sealed upon receipt.Catheter was not repaired.Cracks observed in the blue luer connector.Iodophor was the cleaning agent utilized to clean the adapters.There was no method utilized to tighten the adapters.Tools was not used to loosen or tighten the instruments.There were no any products being utilized with the device.There were no any patient symptoms or complication related to the event.The crrt operation went smoothly.The treatment was completed.There was no reported patient injury.
 
Manufacturer Narrative
H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted there was a hole in the extension tube which led to a leak.Functionally, the distal end of the cannula was clamped and a water bath test was performed.Air bubbles were detected at the connection of the extension tube on the blue port side.A microscope evaluation confirmed a chunk of plastic was cut out of the connection point of the adapter and extension tube.It was reported that there was a leak on the extension tube, and the luer adapter was cracked.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.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.
 
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Brand Name
MAHURKAR
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key10597227
MDR Text Key208950751
Report Number3009211636-2020-00241
Device Sequence Number1
Product Code MPB
UDI-Device Identifier10884521006539
UDI-Public10884521006539
Combination Product (y/n)N
PMA/PMN Number
K030209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 01/26/2021
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 Model Number8888135241
Device Catalogue Number8888135241
Device Lot Number1926700116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Initial Date Manufacturer Received 09/10/2020
Initial Date FDA Received09/28/2020
Supplement Dates Manufacturer Received10/02/2020
12/10/2020
01/07/2021
Supplement Dates FDA Received10/26/2020
01/06/2021
01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
Patient Weight65
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