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: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This product is intended for human use only.Bd does not have animal data for this product family.Veterinary use is considered an off-label use of this product.Additionally, further clinical testing could not be conducted as the tubes were expired at the time of review.Clinical evaluation cannot be conducted on expired tubes.Bd has only validated the use of the product up to and including the day of expiry.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.
|