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)(6) has been listed in and the (b)(6) 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.Initial reporter phone #: an additional phone # was provided as (b)(6).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.Device manufacture date: unknown.(b)(4).
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It was reported that unspecified bd connecta plug experienced 155 cases of foreign matter in the fluid pathway and 37 cases of stopcock/cap loose connection/separation/detachment.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 foreign matter on bd plug (155), the bd plug is loose on bd connecta¿ stopcock(s) (12), and the bd plug inadvertently disconnects from bd connecta¿ stopcock port during use (25).
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