Model Number 22003E-07 |
Device Problems
Complete Blockage (1094); Restricted Flow rate (1248)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2021 |
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 when using the pressure rated ext set bonded ss 8.5, the device experienced flow issues, including a clogged / blocked product.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the set is not flushing.Smartsite extension set is not allowing for flush.
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Event Description
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It was reported when using the pressure rated ext set bonded ss 8.5, the device experienced flow issues, including a clogged / blocked product.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the set is not flushing smartsite extension set is not allowing for flush.
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.It was reported that the set is not flushing.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 22003e-07 lot number 21069758 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A definitive root cause for the customer's experience could not be determined as no needle-free connector (smartsite) was returned.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.Capa 1998036 has been initiated.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston during the assembly process.Fluorosilicone is a lubricant used to ensure proper functioning of the needle-free connector when activated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Search Alerts/Recalls
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