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.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.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customers indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: 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" syringes had issues with leakage, damaged tip caps, difficult plunger movement, and damaged packaging units.The following information was provided by the initial reporter: "it was reported via posiflush pmcf survey that the clinician experienced damaged packaging, damaged syringe tip cap, difficulty opening package, plunger movement difficult and leakage within the past 12 months.".
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