Catalog Number 306593 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Pr (b)(4) : initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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After taking out the package and inspecting it, it was found that there was no needle plug in the unopened package and it could not be used normally.
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Manufacturer Narrative
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(b)(4).Follow up.A device history record review was completed by our quality engineer team for provided material number 306593 and lot number 2153550.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.
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Event Description
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No additional information received after taking out the package and inspecting it, it was found that there was no needle plug in the unopened package and it could not be used normally.
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Search Alerts/Recalls
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