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Catalog Number 300865 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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 bd plastipak¿ concentric luer lock syringe leaked.The following information was provided by the initial reporter, translated from dutch: "at the pharmacy sterile preparations, a spuit luer lock 50 ml 3-part 300865 was noticed on which a defect was present.Namely, a leak is present in the syringe.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 19-may-2023.Investigation summary: one sample and photos received by our quality team for investigation.Upon visual evaluation, it can be observed a damage in the edge of the syringe that could lead to the leakage experienced by customer.A device history review was performed for lot 2303011, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the teams investigation, this damage can be produced during molding process since it is located in the injection points of the part.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.
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Search Alerts/Recalls
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