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.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 summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.A review of the device history record could not be performed as the lot number was unknown.Investigation conclusion: complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Root cause description: since, an investigation could not be performed bd was unable to determine a possible root cause.Rationale: without a sample no corrective actions could be identified.
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It was reported that there was an infection on 10 occasions while using unspecified bd¿ insyte iv catheter.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 occurrences of bloodstream infection (e.G.Blood stream bacteraemia, sepsis) (10), phlebitis (20), infiltration / extravasation (10), and catheter occlusions (10).
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