Catalog Number 305270 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that syringe integra 3ml w/ndl 25x1 rb leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that vaccine is leaking out of the syringe down her customers arm as she is giving the shot.
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Manufacturer Narrative
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Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.
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Event Description
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It was reported that syringe integra 3ml w/ndl 25x1 rb leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that vaccine is leaking out of the syringe down her customers arm as she is giving the shot.
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Search Alerts/Recalls
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