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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 8888135191
Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during dialysis treatment at 17:22, it was found that the blood could not be drawn back and it was all air.It was also stated that it was found or observed that there was a crack on the arterial end port of the heparin cap of the central venous catheter prior to use (the connection between the red port of the artery end and the transparent tube).It was reported to the doctor, the device was extubated, activate the patient's immature internal fistula to continued the treatment and to resolve the issue.The treatment was completed, there was no blood loss and blood transfusion was not required.It was also mentioned that flushing was not performed, there were no other products utilized with the device, the blood of the patient was safely returned, iodophor was used to clean the adapters and to treat the insertion site prior product placement.There was no medical intervention done to the patient, the method that was utilized to tighten the adapters were by hands and the cleaning agent was allowed to dry thoroughly prior to applying the ointment to the area.There was no reported patient injury.
 
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.
 
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, during dialysis treatment at 17:22, it was found that the blood could not be drawn back and it was all air.It was also stated that it was found or observed that there was a crack at the joint of the arterial end port (red end) and central venous catheter prior to use (the connection between the red port of the artery end and the transparent tube).There was no issue on the third port of the catheter.It was reported to the doctor, the device was extubated, activate the patient's immature internal fistula to continued the treatment and to resolve the issue.The treatment was completed, there was no blood loss and blood transfusion was not required.It was also mentioned that flushing was not performed, there were no other products utilized with the device, the blood of the patient was safely returned, iodophor was used to clean the adapters and to treat the insertion site prior product placement.There was no medical intervention done to the patient, the method that was utilized to tighten the adapters were by hands and the cleaning agent was allowed to dry thoroughly prior to applying the ointment to the area.There was no reported patient injury.
 
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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
CS  20101
MDR Report Key12101982
MDR Text Key259596826
Report Number3009211636-2021-00157
Device Sequence Number1
Product Code MPB
UDI-Device Identifier10884521006447
UDI-Public10884521006447
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
Report Date 09/16/2021
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 Date05/28/2024
Device Model Number8888135191
Device Catalogue Number8888135191
Device Lot Number1917200313
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/10/2021
Initial Date FDA Received07/01/2021
Supplement Dates Manufacturer Received06/28/2021
09/11/2021
Supplement Dates FDA Received07/20/2021
09/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
Patient Weight49
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