Catalog Number 990173 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that 27 bd plastipak¿ luer slip syringes experienced leakage.The following information was provided by the initial reporter: luer leakage failures were observed on a production lot of 20ml syringes.
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Manufacturer Narrative
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Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: na.
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Manufacturer Narrative
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Follow up mdr for device evaluation.This defect belongs to a project, which is being discussed with r&d and unit quality.We are performing some tests to be able to determine the root cause of the issue.
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Event Description
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No additional information.
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Search Alerts/Recalls
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