Catalog Number 306595 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/10/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
|
|
Event Description
|
When the product was unpacked, it was found that there was suspected dust and foreign matter on the white heparin cap and the front end of the pre-filled tube; samples can be returned, with photos provided;.
|
|
Manufacturer Narrative
|
Pr (b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 306595 and lot number 3296737.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.H3 other text : see h10 narrative.
|
|
Event Description
|
No additional information received.When the product was unpacked, it was found that there was suspected dust and foreign matter on the white heparin cap and the front end of the pre-filled tube; samples can be returned, with photos provided; green claims are required, and a complaint response letter and acceptance letter are required.
|
|
Search Alerts/Recalls
|