Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.Investigation summary: since a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in your description of the event.Examination of the product involved may provide clarification as to the cause for the reported failure.
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