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 an unspecified bd posiflush syringe had the incorrect fill amount in the pre-filled syringe."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.".
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