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 06/01/2021 |
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 vaccine medicine leaked from the bottom of the bd flu+¿ syringe.The following information was provided by the initial reporter: "vaccine noted to be leaking out of the bottom of the syringe, no injury, syringe filled with vaccine disposed of.".
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed for provided lot number 2012414.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 this incident, twenty retained samples of the same lot number were obtained from the manufacturing facility for further evaluation.The retained samples were examined and no signs of leakage were identified.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.
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Event Description
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It was reported that vaccine medicine leaked from the bottom of the bd flu+¿ syringe.The following information was provided by the initial reporter: "vaccine noted to be leaking out of the bottom of the syringe, no injury, syringe filled with vaccine disposed of.".
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Search Alerts/Recalls
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