Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: (b)(4).The customer's address is unknown.(b)(6) has been used as a default.Medical device expiration date: unknown.Medical device manufacture date: unknown.Investigation summary: exec summary: no samples were returned therefore bd was not able to duplicate or confirm the customers indicated failure and the root cause is undetermined.Unable to perform complaint lot history check owing to an unknown lot number for this event.Capa/sa: based on the above no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) are required at this time.Dhr review: no dhr review can be carried out as the lot number is unknown.
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