It was reported that the unspecified bd phaseal¿ optima injector disconnected from the luer-lock connection to the cadd pump tubing during use.The following information was provided by the initial reporter: "pt stated about 10:35 am this morning, his pump was alarming.Pt stated connection between the phaseal injector and 5fu cadd pump tubing came apart.Blood noted in line.Pt clamped lines and turn pump off, reconnected the line and came to atc.Pt aox3, no distress noted.Pt denies any sob, chest pain, nausea, vomiting, diarrhea, fever, cough.1210 upon arrival to atc, pac line was unable to flush and get blood return.Needle was removed and port was re-access.Flushed and blood return obtained.1230 per pump: total remaining: 137.7ml: total given: 102.35ml as of (b)(6) 2021.1235 treatment restarted.No issues noted.2nd rn verified pump connections.Phaseal injector was placed by the pharmacy.".
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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 the (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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