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.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A dhr could not be performed as the lot# and the catalog# are unknown.No root cause can be determined as no samples were received.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
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