Model Number 8884711253 |
Device Problem
Kinked (1339)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The customer reported that the stylet and the tube have kinks.The customer also states that 9 units of the same product have the same issue.There was no patient injury.
|
|
Manufacturer Narrative
|
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If the sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Nine decontaminated samples were received at the plant for the investigation.Upon a visual evaluation of the sample, the defect was confirmed; the tubing was kinked.The device history record was reviewed and indicated that the product was release accomplishing all quality standards. complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|