Catalog Number 300613 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 stopper on the 20 ml bd¿ eccentric luer slip tip syringe was loose.The following was translated from french to english: the rubber of the plunger of a 20ml syringe is not airtight.The leak occurred while the syringe was being used.
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Event Description
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It was reported that the stopper on the 20 ml bd¿ eccentric luer slip tip syringe was loose.The following was translated from french to english: the rubber of the plunger of a 20ml syringe is not airtight.The leak occurred while the syringe was being used.
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Manufacturer Narrative
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Pr 8971913 follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 2308754, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.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 leakage testing.Ten retained samples of lot 2308754 were used for additional evaluation.The product was visually inspected, no defects or damage was noted on any of the syringe components that could lead to a leak and all stoppers were verified to be properly assembled on to the plunger rod.Leakage testing was performed and product was verified to meet required specification.Based on the available information, we cannot identify a root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
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Search Alerts/Recalls
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