Model Number 515005 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd phaseal¿ injector luer lock (n35c) the injector was loose.There was separation of the injector and mating component.The following information was provided by the initial reporter.The customer stated: "the hcp felt something strange about the injector during use, and stopped using this complaint product and used another product.The injector needle seemed to come out easily.".
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Manufacturer Narrative
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Medical 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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Medical 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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Event Description
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It was reported when using the bd phaseal¿ injector luer lock (n35c) the injector was loose.There was separation of the injector and mating component.The following information was provided by the initial reporter.The customer stated: "the hcp felt something strange about the injector during use, and stopped using this complaint product and used another product.The injector needle seemed to come out easily.".
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Event Description
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It was reported when using the bd phaseal¿ injector luer lock (n35c) the injector was loose.There was separation of the injector and mating component.The following information was provided by the initial reporter.The customer stated: "the hcp felt something strange about the injector during use, and stopped using this complaint product and used another product.The injector needle seemed to come out easily.".
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Manufacturer Narrative
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H6: investigation summary: one injector and photos was provided to our quality team for investigation.Through visual inspection, the injector membrane was noted to have been penetrated multiple times, and the injector grips are moved from their original place.Product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.Fragmentation test is carried out during production, samples are connected to a matting component and penetrated 10 times each for being tested for coring.If any issue would have been occurred it would have been detected during testing.Moreover, a leakage test is also performed.Samples are connected to a matting component and penetrated 10 times each for being tested for leakage.If any issue would have been occurred it would have been detected during testing.As the lot involved in this incident is unknown, a device history review cannot be performed.Based on the investigation and sample evaluation, it was determined this incident is related to improper engagement/disengagement of the device.H3 other text : see h10.
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Search Alerts/Recalls
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