COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
|
Back to Search Results |
|
Model Number 8813817009 |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/28/2022 |
Event Type
malfunction
|
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 the procedure, the guidewire got stuck in between the needle and needle hub.Nothing unusual was observed on the device prior to use.The catheter was not repaired and had no leak.Tego was not utilized.The insertion site was not treated prior to product placement.There was no luer adapter issue.The guidewire had no flaws or damages, such as fraying, coiling, or unraveling.The guidewire was provided with the kit.Flushing the introducer needle prior to use produced normal results with no occlusion.No excessive force was used during insertion or removal.It was also mentioned that resistance had been noted.There were no other products were being utilized with the device.The introducer needle and guide wire were not removed simultaneously from the patient (the guidewire was removed).All guidewire pieces are present and correct, with no broken pieces.There was no dimension issue noted, and both the dimension of the needle and the guide wire matched what was indicated on the label.There was no blood loss, and a blood transfusion was not needed.There was no medical intervention or treatment due to the event.A new catheter was pulled out and implanted as a remedial action.The procedure was completed.There were no patient symptoms or complications associated with this event.There were no reported patient injuries.
|
|
Manufacturer Narrative
|
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the guidewire was damaged and the puncture needle was occluded by something that could not be removed.It was reported that the guide wire was unable to be withdrawn.The reported issue was confirmed.The most likely cause was not traced to the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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
|
|
|