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Catalog Number 300865 |
Device Problem
Fungus in Device Environment (2316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/16/2020 |
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 product smelled moldy with a bd plastipak¿ 50 ml concentric luer lock syringe.The following information was provided by the initial reporter: one of the end-users contacted distributor about their plastipak, smelled bad, moldy, odor.The end user wanted another package with fresh plastipak.The distributor went to where the plastipaks are placed.But they were also smelling bad (moldy, odor).They have 5520 pieces (92 boxes) that they now want to discard.
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Manufacturer Narrative
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Additional information d.10 device available for eval yes, returned to manufacturer on: 2020-03-30 h.6.Investigation summary one closed box with sixty samples were provided to our quality team for investigation.The box was visually inspected, no humidity was observed on the cardboard, there were no drops of water identified outside the syringe containers, and no odor was detected.A device history review was performed for reported lot 1912289, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.We have reviewed the sterilization cycle and inspections for this lot and found all results met required specifications.There have been no changes in the manufacturing process or materials used to manufacture this product.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.Based upon the visual inspection of the samples received and the quality team's investigation, we were unable to determine the root cause for the alleged defect at this time.Complaints received for this defect and device will be monitored by our quality team for future occurrences.
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Event Description
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It was reported that the product smelled moldy with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter: one of the end-users contacted distributor about their plastipak, smelled bad, moldy-odor.The end-user wanted another package with fresh plastipak.The distributor went to where the plastipaks are placed.But they were also smelling bad (moldy-odor).They have 5520 pieces (92 boxes) that they now want to discard.
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Search Alerts/Recalls
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