COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
|
Back to Search Results |
|
Model Number 8831661001 |
Device Problems
Material Fragmentation (1261); Product Quality Problem (1506); Difficult to Remove (1528); Obstruction of Flow (2423)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/23/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, initially there was a problem inserting the cvc (central venous catheter) into the right femoral.It was stated that the catheter immediately had problems and was removed.The following day, the customer reported that the guide wire did not pass.It was stated that it was placed for start of chronic dialysis and placement was said to be ultrasound guided.The functionality was sufficient and with heparin lock.Venous priming was 1.3 and arterial priming was 1.2.The catheter was not repaired.There was no leak and no luer adapter issue.Tego was not utilized.There was no patient symptoms or complications associated with this event.There was no reported patient injury.
|
|
Event Description
|
According to reporter, on (b)(6), 2022 (friday) a contralateral central venous catheter (cvc) was placed and had to be remove the following day for internal organizational problems.During replacement, there was a problem of insertion of the guidewire (includedin the kit).It was stated that the guidewire was pinned (did not pass) inside the catheter and did not come out in the tip of the catheter.When removed the guidewire was folded and all pieces were accounted for.Another catheter of the same batch was implanted and had no problem.It was stated that it was placed for start of acute dialysis and placement was said to be ultrasound guided.The functionality was sufficient and with heparin lock.Venous priming was 1.3 and arterial priming was 1.2.The catheter was not repaired.There was no leak and no luer adapter issue.Tego was not utilized.There was nothing unusual observed on the device prior to use, flushing was done prior to use with no problem, no other defects/damages found on the product, no excessive force was used on the device and only heparin was the cleaning agent used on the device.Intervention/treatment was not required as a result of the event.There was no blood loss, and blood transfusion was not required.There was no patient symptoms or complications associated with this event.There was no reported patient injury.
|
|
Manufacturer Narrative
|
Additional information: b3, b5, d9, g3, h3, h6 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
|
Additional information: b5, g3, h6 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, on (b)(6), 2022 the removal of the catheter was evaluated and to make sure to dialysis the patient, another central venous catheter (cvc) was in placed.The following day (b)(6) 2022, the central venous catheter (cvc) was removed and replaced.During replacement, there was a problem with the guidewire (included in the kit).It was stated that the guidewire was pinned (did not pass) and did not allow replacement.When removed the guidewire was not intact and all pieces were accounted for.It was stated that it was placed for start of chronic dialysis and placement was said to be ultrasound guided.The functionality was sufficient and with heparin lock.Venous priming was 1.3 and arterial priming was 1.2.The catheter was not repaired.There was no leak and no luer adapter issue.Tego was not utilized.There was nothing unusual observed on the device prior to use, flushing was done prior to use with no problem, no other defects/damages found on the product, no excessive force was used on the device, only heparin was the cleaning agent used on the device and intervention/treatment was not required as a result of the event.There was no blood loss, and blood transfusion was not required.There was no patient symptoms or complications associated with this event.There was no reported patient injury.
|
|
Manufacturer Narrative
|
Additional information: g1, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the guide wire was unable to be withdrawn and there was a guide wire issue.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.
|
|
Search Alerts/Recalls
|
|
|