Model Number 309653 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 during use there was leakage past the stopper with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, translated from (b)(6) to english: new 60 ml syringes leak past stopper, it happened more times.
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Manufacturer Narrative
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H.6.Investigation summary: no samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed.While a definitive root cause could not be determined, leakage can be caused by the interaction between the barrel inside diameter, the stopper outside diameter, and plunger rod bayonet outside diameter and forces applied during use.The syringe is more likely to leak when forces are applied to the plunger rod when fully extended.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.H3 other text : see section h.10.
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Event Description
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It was reported that during use there was leakage past the stopper with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, translated from dutch to english: new 60 ml syringes leak past stopper, it happened more times.
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Search Alerts/Recalls
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