BECTON DICKINSON, S.A. BD LUER-LOCK CONNECTOR FOR USE WITH NEEDLE-FREE PORTS; INTRAVASCULAR ADMINISTRATION SET
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Model Number 515202 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2021 |
Event Type
malfunction
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Event Description
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It was reported that bd luer-lock connector for use with needle-free ports was damaged, but still operable.The following information was provided by the initial reporter: " it was reported luer lock disconnection.".
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H6: investigation summary no sample or photo of the used connector was provided to our quality team.A device history review was performed for the reported lot 2105208, no deviations or non-conformities were identified during the manufacturing process that could have contributed to the alleged defect.Five retained samples were used for further evaluation.The product was visually inspected and no damage or defects were observed.Samples were functionally tested by connecting a sample syringe and injector to a sample protector along with the vial according to the instructions for use.Liquid was successfully aspirated from the vial and then the injector was connected to the retained sample connectors.In all cases, the liquid could flow correctly from the syringe through the injector and the connector without problem and without resistance.The product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification of flow rate and confirmation that all critical parts are within specifications, all have been checked.Records for the reported lot and the results were found to be acceptable.Based on the information available, we are unable to determine a root cause at this time.
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Event Description
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It was reported that bd luer-lock connector for use with needle-free ports was damaged, but still operable.The following information was provided by the initial reporter: " it was reported luer lock disconnection.".
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Search Alerts/Recalls
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