BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA CONNECTOR (C35-O); INTRAVASCULAR ADMINISTRATION SET
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Catalog Number 515070 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that the tubing disconnected from the bd phaseal¿ optima connector (c35-o) during use.The following information was provided by the initial reporter: "patient has a cadd pump and she stated that around 6:45 in the morning today, the tubing was disconnected from the phaseal connector but she was able to reconnect it immediately, she claimed to not have seen any leakage of fluids from the tubing and no blood came out from the line.".
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Search Alerts/Recalls
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