Catalog Number 301035 |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that before use of the bd¿ luer lok syringe there was a hair inside a syringe.The following information was provided by the initial reporter: material no.301035, batch no.8023808."it was reported that there was hair found inside the syringes.".
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Event Description
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It was reported that before use of the bd¿ luer lok syringe there was a hair inside a syringe.The following information was provided by the initial reporter: material no.301035 batch no.8023808."it was reported that there was hair found inside the syringes.
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Manufacturer Narrative
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Investigation: one (1) photo was received by our quality team.The photo appears to show a faint line in the syringe indicating a possible fiber in the syringe.However, without a physical sample to analyze the composition of the fiber can't be determined.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.Without a physical sample to analyze the foreign matter (fm) that appears to be in the syringe cannot be identified; therefore, potential root causes cannot be determined.
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Search Alerts/Recalls
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