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.Date of event: unknown.The date received by manufacturer has been used.Medical 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 5 unspecified bd¿ syringes leaked, 10 syringes had barrel/flange damage, 2 syringes had open packaging, and 5 syringes had issues with exposing the clinician to blood/bodily fluids.The following information was provided by the initial reporter: "it was reported via survey response that the clinician encountered leakage, barrel/flange damaged, difficulty drawing fluid/medication into syringe, package open before use and the clinician exposure to blood/body fluids related to luer lok and luer slip tip syringes.".
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