Catalog Number 301073 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Information (3190)
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Event Date 12/10/2018 |
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.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 bd¿ syringe luer-lok tip w/tip shield bulk non-sterile was contaminated with unknown brown substance.
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Manufacturer Narrative
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Investigation summary: one photo and one 3ml ll syringe sample inside an opened blister package were received.The physical sample appeared to match the one depicted in the photo.The package used was from a different batch #8253851 and different product (p/n 305060) from one reported.A visual evaluation of the sample determined an embedded foreign matter defect.Multiple brown particles were observed embedded in the barrel wall above the 3ml mark as well as within the flange.At least one particle was larger than level 3 in size, which is rejectable per product specification.The barrel was confirmed to be from mold c-238 cavity 78.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Potential root cause for the embedded foreign matter defect is associated with the molding process.No corrective actions are necessary based on the defective rate identified.
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Event Description
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It was reported that bd¿ syringe luer-lok tip w/tip shield bulk non-sterile was contaminated with unknown brown substance.
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Search Alerts/Recalls
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