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Model Number 8881513934 |
Device Problems
Break (1069); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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The customer reported that when drawing the vaccination up, they are noticing there is a constant introduction of air into the syringe from the rubber stopper.It sort of looks like the liquid is simmering.They were trying to diagnose what was going on exactly, and the middle tip part of the syringe snapped.When they see the "simmering", they push the vaccination back into the vial, throw that syringe away and grab another one from the box.Again, that is about 15%-25% of the syringes that they are tossing.Per additional information received, the syringe snapped at the luer lock area.They tossed the syringes and used new ones without the defect for vaccinations.Medical intervention was not required.
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Manufacturer Narrative
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Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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