COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
|
Back to Search Results |
|
Model Number 8813793013 |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 06/27/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, prior to use, on package opening, it was noted that the catheter was bent near the tip.The catheter was not repaired, no cleaning agents was used, tego was not utilized, there was no luer adapter issue.There was no patient involvement.
|
|
Event Description
|
According to the reporter, prior to use, on package opening, it was noted that the catheter was bent near the tip.It was reported that there was no packaging damage, nothing else unusual was observed on the device.The catheter was not repaired, no cleaning agents was used, tego was not utilized, there was no luer adapter issue.There was no patient involvement.
|
|
Manufacturer Narrative
|
H6 h3 evaluation summary: post market vigilance (pmv) led a photographic evaluation of a device.The first photo depicts the catheter on yellow paper, the tip is bent.The second photo depicts a close-up view of the bent catheter tip.The third photo depicts the product identification label.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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
|
|
|