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 in (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.Device expiration date: unknown.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.
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It was reported that unspecified bd connecta devices experienced 1 case of flow issues, 2 cases of leakage, and 2 cases of tubing separation from adapter/luer connection.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 no flow or reduced flow of fluids (1), leakage (2), and the tubing disconnects from stopcock (2).
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