Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).Medical device expiration date: unknown.Initial reporter additional phone#: (b)(4).Device manufacture date: unknown.(b)(4).Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
|
It was reported that there was an infection after using unspecified bd¿ catheter.This occurred on 10 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via post market survey that the clinician encountered infiltration / extravasation (10), blood stream infection (e.G.Blood stream bacteraemia, sepsis) (10) and hematoma (10).
|