Catalog Number 305839 |
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 06/11/2021 |
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 8 syringes flu plus 0.1-1ml var dose 23x1 leaked under the bevel when drawing up vaccine medicine.The following information was provided by the initial reporter: "there have been at least 8 syringes which have leaked under the bevel when the vaccinators have been drawing up.".
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Event Description
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It was reported that 8 syringes flu plus 0.1-1ml var dose 23x1 leaked under the bevel when drawing up vaccine medicine.The following information was provided by the initial reporter: "there have been at least 8 syringes which have leaked under the bevel when the vaccinators have been drawing up.".
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed for provided lot number 2102408.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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Search Alerts/Recalls
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