Catalog Number 990687 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.(b)(6).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 there were issues with needle being secure in the bd syringe¿ plastipak 20ml ll s/su.
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Manufacturer Narrative
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Investigation: a batch history analysis was performed, quality notifications and maintenance records were verified where no records related to failure were found.The sample was analyzed and it was possible to identify a small deformity in the first thread of the luer lock (nozzle of the syringe).This deformity was causing the difficulty of attachment to the syringe.We evaluated the press and the mold and we found out a gap in the mold rack assembly (device used to extract the nozzle from the syringe).The problem was corrected by replacing the screw which was causing the clearance in the rack assembly according to maintenance order (b)(4).
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Event Description
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It was reported there were issues with needle being secure in the bd syringe¿ plastipak 20ml ll s/su.
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Search Alerts/Recalls
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