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Catalog Number 300223 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.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 an unspecified number of syringe non sterile 50ml ll experienced product damage and leakage.The following information was provided by the initial reporter: customer reported that the syringe is leaking considerably, there is a huge crack on the syringe lengthwise.Product: 300223, batch 1610704p.The syringe has been filled and was already in the pump for administration, but fortunately (because of the risk of contamination) it has not yet been administered.
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Manufacturer Narrative
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Investigation: one sample and one photo were provided to our quality engineer for investigation.Through visual inspection, a crack is observed on the barrel, extending to the 40 ml marking.A device history review was performed for reported lot 1610704p, finding one annotation that could be related to the reported defect.During the marking process, a malfunction was detected in the marking machine that resulted in barrels becoming jammed in the barrel feeding wheel.Once detected, the mechanical team repaired the failure and impacted units were scrapped.It was determined the issue you reported is related to this malfunction.
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Event Description
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It was reported that an unspecified number of syringe non sterile 50ml ll experienced product damage and leakage.The following information was provided by the initial reporter: customer reported that the syringe is leaking considerably, there is a huge crack on the syringe lengthwise.Product: 300223, batch 1610704p.The syringe has been filled and was already in the pump for administration, but fortunately (because of the risk of contamination) it has not yet been administered.
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Search Alerts/Recalls
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