The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The customer states the luer lock of a 1" needle did not screw on to the syringe causing the vaccine solution to spray on the nurse, mother and baby being vaccinated.According to the customer, no medical attention was needed by anyone involved and there was no harm to anyone involved.
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