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 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 the unspecified bd posiflush syringe experienced an incorrect fill -less than specifications, scale marking issues, difficult plunger movement, and stopper separation from the plunger.The following information was provided by the initial reporter: material no:unknown batch no: unknown.It was reported via posiflush pmcf survey that the clinician experienced inadequate flushing, difficulty connecting to the needleless system, scale marking issues and plunger movement difficult and the stopper separated from the plunger within the past 12 months.
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