Model Number 300613 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 that bd plastipak¿ 20 ml syringe had molding defects.This occurred on 3 occasions during use.The following information was provided by the initial reporter: poor cutting of plastic handles (raw edges), resulting in cuts by medical staff.
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Manufacturer Narrative
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H.6.Investigation summary: three samples and one photo were provided to our quality team for investigation.The product was visually inspected, burrs were observed along the plunger.This defect can be caused during the molding process.A device history review was performed for reported lot 1907298, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.The areas where pieces run in manufacturing equipment are protected to avoid damage on the 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 on the available information we cannot identify a definitive root cause at this time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
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Event Description
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It was reported that bd plastipak¿ 20 ml syringe had molding defects.This occurred on 3 occasions during use.The following information was provided by the initial reporter: poor cutting of plastic handles (raw edges), resulting in cuts by medical staff.
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Search Alerts/Recalls
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