Model Number 306547 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/19/2020 |
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.
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Event Description
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It was reported that breakage occurred during use with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, "part of syringe broke off inside of tubing connector.".
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Manufacturer Narrative
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H.6.Investigation summary: it was reported the item was broken.This is the 1st complaint for lot # 0031403 for this type of defect or symptom.A device history review was conducted for lot number 0031403.There was no documentation for this type of defect during the entire production run of this batch.Three photos were provided.One photo shows a syringe and an iv extension set.The two other photos show a document/ report the posiflush platform was contacted.After an investigation with the dchu it was confirmed that an onsite investigation was performed.Findings from the site visit determined that there is most likely a correlation to the usage of alcohol products (in the form of tips) and the incidences of cracked, broken or crumbled fixed collars on make luer end of set me2017.If proper dry times are not followed after scrubbing the hub, alcohol binding may result causing the reported failure modes.With the continued use of alcohol products; bd has proposed alternate products that will have improved product performance.The improved chemical resistance, including alcohol resistance, is due to the materials used in manufacturing the male and female luers.Root cause: can¿t be confirmed.Nothing in the bd manufacturing process has been identified that could contribute to this failure mode.H3 other text : see h.10.
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Event Description
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It was reported that breakage occurred during use with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, "part of syringe broke off inside of tubing connector.".
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Search Alerts/Recalls
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