Catalog Number 300869 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that syringe 50ml ll amber stopper was defective.The following information was provided by the initial reporter: they report to have found the rubber of the plunger defective.
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Manufacturer Narrative
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H.6.Investigation: one sample received for investigation, upon visual inspection of the sample received it can be observed the stopper is not correctly assembled.The rest of the components do not present any defect, when the stopper is disassembled, no defects can be seen.A device history review was performed for reported lot 2006307, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.In assembly stations of 50ll manufacturing lines there is a vision system to detect stoppers bad assembled or missing stopper.In case any is defective it is rejected automatically to scrap.Possible root cause of the non-conformance is related with a misalignment of plunger-stopper-barrel in the assembly station.
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Event Description
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It was reported that syringe 50ml ll amber stopper was defective.The following information was provided by the initial reporter: they report to have found the rubber of the plunger defective.
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Search Alerts/Recalls
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