Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.Device manufacture date: unknown.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.(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 an unspecified bd posiflush syringe had an incorrect fill.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 resulting in cannula replacement, difficulty connecting to port, valve, and / or needleless system and stopper separation from plunger within the past 12 months.Event description per email states:".
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