Catalog Number 309653 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/26/2019 |
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.The customer's address is unknown: (b)(6) has been used as a default.
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Event Description
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It was reported that foreign matter occurred with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter."material no.309653, batch no.8303990.It was reported there is foreign matter in the syringe."i have another quality report.A 60cc syringe was sent to me with what appears to be dirt in the sealed packaging.Ref: (b)(4), lot: 8303990".
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Manufacturer Narrative
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H.6.Investigation: one (1) photo was provided by the customer.It shows the end of a syringe in a blister pack.There appears to be black foreign matter (fm) in or on the packaging.Additionally, a sample was received.There is black foreign matter (fm) sealed inside the packaging.The foreign matter (fm) was identified as grease.Grease likely got on the plunger rod during the molding process.If the plunger rod would come in contact with the areas outside of the mold face and the good product chute, it could potentially come in contact with grease on the press.There is part containment in place to try and mitigate the issue, but due to static on the mold face the plunger rods can sometimes land in unpredictable locations.These parts can potentially fall back into the chute due to the vibration of the press.A device history record review was completed with zero defects found relating to foreign matter.No quality notifications were written for this batch, nor for the associated assembly batches.
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Event Description
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It was reported that foreign matter occurred with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter: "material no.309653.Batch no.8303990.It was reported there is foreign matter in the syringe."i have another quality report.A 60cc syringe was sent to me with what appears to be dirt in the sealed packaging.Ref: 309653.Lot: 8303990.".
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Search Alerts/Recalls
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