BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INJECTOR (N35-O); INTRAVASCULAR ADMINISTRATION SET
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Catalog Number 515052 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or physical samples were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification.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 related to the device at this time.It is important to ensure all luer connections are securely tightened before use.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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Event Description
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It was reported that at least one bd phaseal optima injector (n35-o) experienced a loose injector and separation of injector and mating component.The following information was provided by the initial reporter: last week on my patient rounds, i noticed that the chemo iv line was attached but the luer lock not engaged.So if there was enough tension on the line it would have disconnected.I have been huddling with the nurses to tighten all connections when hanging.Also when we twist luer lock to tighten, we have to hold the blue part otherwise it just spins and the lock is not tight.Additional information received: they had a disconnection with the injector, probably due to the lack of correct connection with the two pieces luer-lock.
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