Medical device expiration date: unknown.Device manufacture date: unknown.A sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
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The following information was reported to bd via medwatch mw5070293: ct exams with issue, approx 3 hours after exams, radiologist when reading exam noted air embolus.Injector syringe: lot 8528682, cat sds-ctp-spk, iv needle bd nexiva 22g, closed iv catheter system additional information could not be obtained as contact information for the customer was not provided.
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