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Catalog Number 405259 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3.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 5 of the bd¿ quincke spinal needle experienced leakage at the hub.The following information was provided by the initial reporter, translated from siamese to english: spinal needle is leak in hub area when connect with syringe.
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Manufacturer Narrative
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H6: investigation summary no samples or photos received by our quality team for evaluation.A device history review was performed for the reported lot 2205010 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples from the same lot were used for additional evaluation.The product was visually inspected, no damage or cracks were observed on or near the luer connection.Functional testing was performed, connecting the needle to a syringe.Liquid was able to pass from the syringe through the needle and no leakage was observed.Product is visually and functionally tested throughout manufacturing according to procedure, verifying all critical dimensions are within specification.Testing results for lot 2205010 verified product met all required limits.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.
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Event Description
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It was reported that 5 of the bd¿ quincke spinal needle experienced leakage at the hub.The following information was provided by the initial reporter, translated from siamese to english spinal needle is leak in hub area when connect with syringe.
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Search Alerts/Recalls
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