Date of event: unknown.The date received by manufacturer has been used for this field.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.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no lot information or sample was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.
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It was reported that the bd phaseal optima injector (n35-o) experienced an injector that was loose or separation of injector and mating component, and flow issues (when used for infusion).The following information was provided by the initial reporter: bd085 during shower, patient's injector/connector became disconnected and blood began to backflow from patient's picc line (clampshell was in place during this time).Capp, injector/connector were replaced; line cleaned with sani-cloth; housekeeping called to disinfect bathroom.Additional details from customer: it was reported between injector and connector.
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