BECTON DICKINSON MEDICAL SYSTEMS 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE
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Catalog Number 306510 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Bacterial Infection (1735)
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Event Date 05/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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The fda was made aware of this incident via voluntary medwatch 5077799.This information was communicated to bd on 6/25/2018 by the fda.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 a patient contracted an infection after using a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml.It is unknown if medical intervention was provided.Out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.Food and drug administration (fda) and (b)(6) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and (b)(6) identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.(b)(6)'s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, fda, and (b)(6).
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Event Description
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It was reported that a patient contracted an infection after using a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml.It is unknown if medical intervention was provided.*out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.Food and drug administration (fda) and centers for disease control and prevention (cdc) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and cdc identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.Cdc¿s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, fda, and cdc.
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Manufacturer Narrative
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Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: male event attributed to: other device single use?: no device returned to manufacture: no.
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Manufacturer Narrative
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Investigation summary: lot number 725291n for product code 306510 was provided for evaluation by our quality engineer team.Upon reviewing the production history for the provided lot number, no deviations or non-conformances were identified during the manufacturing process.A corrective and preventive action plan was initiated to further investigate and monitor this issue.One-hundred and twenty retained samples for the lot number provided were visually inspected and no abnormalities were observed in regards to the solution.A review of all lot sterility testing performed for product released between april 2015 and june 2018 confirmed that no organism growth was identified for any lots released during the shelf-life of this product.Multiple samples produced before and after the provided lot number were sent for sterility testing and confirmed that no microbial growth was exhibited after incubation.This in combination with the daily environmental monitoring and sterility testing provides confidence in the sterility of the reported lot number.Prior to the report of infection evaluated in (b)(4), there was no trend for infection cases reported for (b)(4) product.This complaint is part of a new trend which began in april 2018.Capa 350041 was initiated to address this issue.100% of retained samples for the lot (120 units) were visually inspected.No growth was seen (i.E., the solution was clear).Lot 725291n was manufactured between lots 725271n and 725591n, both of which exhibited no growth during the confirmatory sterility testing.This, in combination with the daily environmental monitoring and original sterility testing for the lot release, provides confidence in the sterility of the complaint lot.A review of all lot sterility testing performed for product released between april 015 & june 2018 confirmed that no organism growth was identified for any lots released during the shelf life of this product.A review of the dhr and supporting documentation for lot 725291n was performed.There were no deviations, non-conformances, or out of specifications related to the manufacture of lot 725291n or the raw materials used to manufacture this lot.The root cause analysis of the reported infection cases under capa 350041 has not identified a direct causation between the infections and the bd (b)(4) product.
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Event Description
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"it was reported that a patient contracted an infection after using a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml.It is unknown if medical intervention was provided.Out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.Food and drug administration (fda) and centers for disease control and prevention (cdc) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and cdc identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.Cdc¿s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, fda, and cdc.".
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