Catalog Number 300865 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2021 |
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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2104094.Medical device expiration date: 03/31/2026.Device manufacture date: 04/20/2021.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: 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 two syringe 50ml ll had leakage issues.The following information was provided by the initial reporter, translated from (b)(6): "when preparing chemotherapy bags, the fluid leaked to the piston.This event was repeated a second time, on a different day, with a syringe of the same reference.".
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Event Description
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It was reported two syringe 50ml ll had leakage issues.The following information was provided by the initial reporter, translated from french: "when preparing chemotherapy bags, the fluid leaked to the piston.This event was repeated a second time, on a different day, with a syringe of the same reference.".
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Manufacturer Narrative
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H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 2104094, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Ten retained samples of lot 2104094 were used for additional evaluation.The product was visually inspected, no defects or damage was noted and the stopper was properly assembled onto the plunger rod.
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Search Alerts/Recalls
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