BECTON DICKINSON, S.A. BD PHASEAL C35J LUER LOCK CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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Catalog Number 515204 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2021 |
Event Type
malfunction
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Event Description
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It was reported that the bd phaseal c35j luer lock connector experienced leakage, and a separation of the connector and mating component.The following information was provided by the initial reporter: this is a report about leakage with the use of 515505-zat.After preparation of an anticancer agent using a syringe, the hcp pushed the fluid into the infusion bag, and then saw disconnection of connector and the tubing.The customer states that the connection seemed to be loose and was detached easily, resulting in leakage.
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Manufacturer Narrative
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H6: investigation: no samples or photos received for investigation.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 our investigation we are not able to identify a root cause related to our manufacturing process at this time.
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Event Description
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It was reported that the bd phaseal c35j luer lock connector experienced leakage, and a separation of the connector and mating component.The following information was provided by the initial reporter: this is a report about leakage with the use of 515505-zat.After preparation of an anticancer agent using a syringe, the hcp pushed the fluid into the infusion bag, and then saw disconnection of connector and the tubing.The customer states that the connection seemed to be loose and was detached easily, resulting in leakage.
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Search Alerts/Recalls
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