Catalog Number 405164 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that medication leaked from the bd¿ spinal needle with quincke bevel and syringe connection site during use.The following information was provided by the initial reporter, translated from spanish: "when the syringe is connected to the needle, the medication leaks and much of it is lost, the syringe is not well attached to the needle, which causes much of the medication to be lost.".
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Manufacturer Narrative
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H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that medication leaked from the bd¿ spinal needle with quincke bevel and syringe connection site during use.The following information was provided by the initial reporter, translated from spanish: "when the syringe is connected to the needle, the medication leaks and much of it is lost, the syringe is not well attached to the needle, which causes much of the medication to be lost.".
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Manufacturer Narrative
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Investigation summary: one video received by our quality team for investigation.Through visual evaluation, it is observed the process of a puncture is being performed, during this process the syringe leaks through the upper part of the hub.A device history review was performed for lot 2108321, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
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Search Alerts/Recalls
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