Date of death: unknown.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.Device manufacture date: unknown.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.Root cause is undetermined.No sample, lot, or batch provided.
|
It was reported that there was an infection on 41 occasions while using unspecified bd¿ angiocath catheter.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported via post market survey that clinicians encountered occurrences of bloodstream infections (e.G.Blood stream bacteraemia, sepsis) (41), phlebitis (134), infiltration / extravasation (220), catheter occlusions (174), and primer failure (1).Additional information related to bloodstream infection: "wide-spectrum antibiotic therapy and long hospital" (528).Additional information related to bloodstream infection: "antibiotic therapy." (568).Additional information related to death following bloodstream infection: "a death by sepsis took place that could be related or not with the use of the catheter, because the sepsis could be due to another type of catheter or by surgery practiced to the patient.As i always say in this type of surveys the answers are rather approximate, as it is impossible to keep a complete track of each patient from the last years i¿ve been working." (568).
|