Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
H.6.Investigation summary: as bd life sciences - preanalytical systems had not received any sample, photo, catalog number, and/or lot number from the customer facility for evaluation, an investigation could not be performed as no information was available for review.Bd technical services provided product handling information.Investigation conclusion: as bd life sciences - preanalytical systems had not received any sample, photo, catalog number, and/or lot number from the customer facility for evaluation, an investigation could not be performed as no information was available for review.Bd technical services provided product handling information.Root cause description: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.
|