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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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| Model Number 8813817009 |
| Device Problems
Obstruction of Flow (2423); Difficult to Advance (2920)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 01/06/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during catheter insertion in a patient with chronic kidney disease, the guide wire was reported to be stuck as it did not come out of the venous end of the adapter.It was noted that the catheter was not repaired, tego was not utilized, and there was no luer adapter issue.Betadine was the cleaning agent used on the device and the insertion site was treated prior to product placement.There was no leakage noted.The device was replaced in order to resolve the issue.The patient was reported to have more blood loss.There was no patient injury.
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Manufacturer Narrative
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Correction: manufacturer's information 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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Event Description
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According to the reporter, during catheter insertion in a patient with chronic kidney disease, the guide wire was reported to be stuck as it did not come out of the venous end of the adapter.It was noted that the catheter was not repaired, tego was not utilized, and there was no luer adapter issue.Betadine was the cleaning agent used on the device and the insertion site was treated prior to product placement.There was nothing unusual found on the device prior to use.The guide wire used was confirmed to be included in the kit.There was no leakage noted.Flushing was done with no reported issues.There was no damage (not frayed or coiled) found in the guide wire and this was reported to be intact once removed.The guide wire was removed easily and completely with no excessive forces used.X-ray was not done.The device was replaced in order to resolve the issue and treatment was completed.There was a little amount of blood loss of about 10 to 15 milliliters.Patient was reported to have more blood loss.There was no patient injury.
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Manufacturer Narrative
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Additional information: b5, d10, g4, h3, h6.This event has been reassessed and found not to be a reportable event and is not associated with a serious injury or potential for serious injury with reoccurrence.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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Manufacturer Narrative
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Additional information: g4, h3, h6 h3.Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the catheter, introducer needles, guide wire, dilators, wound dressing and sealing caps appeared intact.A functional evaluation found that , the catheter was submerged into a water bath.The ends were clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.The guide wire was inserted and passed through with no occlusion.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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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