It was reported that ganciclovir leaked from the unspecified bd phaseal¿ injector connection to the syringe pump tubing during use.The following information was provided by the initial reporter: "ganciclovir was found to be leaking at phaseal connection to syringe pump tubing.Med comes primed with syringe tubing attached from pharmacy as it is a hazardous med.At end of infusion, a small puddle of med was noted on floor.Unable to tell how much patient received.Of note, med was delivered with phaseal engaged (not showing blue) at connection to the syringe pump tubing".
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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 (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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