Catalog Number 300865 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2020 |
Event Type
malfunction
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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.(b)(4).
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Event Description
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It was reported that 3 bd plastipak¿ 50ml concentric luer lock syringes experienced leakage.The following information was provided by the initial reporter: drug leakage from the tip.
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Manufacturer Narrative
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H.6.Investigation: three photos were provided to our quality team for investigation.Through visual inspection, the photos display two 50mlll plastipak syringes used in a tray and leakage can be observed in the tray.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, including tip and thread verification tests.As the lot involved in this incident is unknown, a device history review could not be performed and additional retained samples could not be evaluated.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.H3 other text : see h.10.
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Event Description
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It was reported that 3 bd plastipak¿ 50ml concentric luer lock syringes experienced leakage.The following information was provided by the initial reporter: drug leakage from the tip.
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Search Alerts/Recalls
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