Model Number 309604 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd luer-lok tip 10-ml syringe the stopper was misaligned.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported multiple defects, including fm (dirt), printing issues, and damaged components, in a total of 35 products.
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Event Description
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It was reported while using bd luer-lok tip 10-ml syringe the stopper was misaligned.This occurred (b)(4) times.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported multiple defects, including fm (dirt), printing issues, and damaged components, in a total of (b)(4) products.
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Manufacturer Narrative
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H.6.Investigation summary: thirty five samples and photos received by our quality team for investigation.Through visual evaluation, foreign matter such as embedded particles, black dots, and ink stains observed on 12 syringes, 10 observed with incomplete marking scale, 6 with damaged barrel, jammed stopper on 3 syringes, and 4 with molding defect at the tip of syringe.A device history review was performed for lot 2045798, no deviations or non-conformances were identified during the manufacturing process that could have contributed to scale marking, damaged barrel, jammed stopper, and molding defect.Based on the quality teams investigation, the root cause for jammed stopper is misalignment of plunger-stopper-barrel in the assembly station, damaged barrel and molding defect is due to poor condition of conveyor belt, scale marking is due to ink level sensor, and foreign matter is embedded burnt material from molding process.This defect appeared due to the injection of burnt material generated during molding process.Before the injection machine is restarted up it is purged until the material is acceptable rejecting the first pieces.Injection machines are periodically subjected to maintenance and cleaning program.Manufacturing personnel have been notified and additional training to reinforce proper assembly has been performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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