Catalog Number 305832 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/02/2021 |
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, a supplemental report will be filed.
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Event Description
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It was reported that the bd flu+¿ syringe leaked when drawing up the vaccine.The following information was provided by the initial reporter: "when drawing up the vaccine, the contents of the syringe leaks into the barrow of teh syringe".
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Event Description
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It was reported that the bd flu+¿ syringe leaked when drawing up the vaccine.The following information was provided by the initial reporter: "when drawing up the vaccine, the contents of the syringe leaks into the barrow of teh syringe".
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed for provided lot number 2101404.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples of the same lot number were obtained for evaluation.The retained samples were examined and no signs of leakage were observed in any of the syringes.Based on the investigation results, an exact cause could not be determined for this incident.
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Search Alerts/Recalls
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