Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples (including photos) were returned for the reported issue of ¿needle stick injury¿, with reported lot # unknown regarding item # 305945, the complaint could not be confirmed, and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Unable to complete dhr check as the lot number is unknown.Bd was not able to duplicate or confirm the indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the investigation, no additional investigation and no capa is required at this time.
|