Catalog Number 309571 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 the syringe 3ml ll w/ndl 23x1 rb experienced cracking and leakage.The following information was provided by the initial reporter: material no.: 309571, batch no.: 9056847.It was reported one syringe cracked and leaked.
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Manufacturer Narrative
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Investigation: one 3ml syringe in an opened blister pack from batch #9056847 (p/n 309571) was received and evaluated.It was observed there was a lengthwise crack in the barrel extending from the 1/2ml to the 1 1/2ml marking.There were also some dried white fluid droplets present on the inside and outside of the barrel and on the plunger rod.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Potential root cause for the damaged barrel defect is associated with the assembly process.
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Event Description
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It was reported that the syringe 3ml ll w/ndl 23x1 rb experienced cracking and leakage.The following information was provided by the initial reporter: material no.: 309571 batch no.: 9056847.It was reported one syringe cracked and leaked.
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Search Alerts/Recalls
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