Catalog Number UNKNOWN |
Device Problems
Nonstandard Device (1420); Contamination of Device Ingredient or Reagent (2901)
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Patient Problems
Unspecified Infection (1930); Chills (2191)
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Event Date 06/21/2018 |
Event Type
Injury
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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 that a patient with, "kidney issues for quite some time," was using unspecified bd posiflush¿ normal saline syringes twice a day to flush her ports.In (b)(6), the patient had a kidney infection and blood cultures were taken.The patient experienced fever and chills, was admitted to a hospital for seven days, and received antibiotics.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 (b)(4) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the (b)(4) identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.(b)(4)¿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, (b)(4).
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Event Description
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It was reported that a patient with, "kidney issues for quite some time," was using unspecified bd posiflush¿ normal saline syringes twice a day to flush her ports.In april, the patient had a kidney infection and blood cultures were taken.The patient experienced fever and chills, was admitted to a hospital for seven days, and received antibiotics.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 (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: female, event attributed to: other, device single use? no, device returned to manufacture: no.Investigation summary: as no product code, lot number, or sample was available for this incident, a full investigation consisting of a sample analysis and a device history record review could not be completed.Prior to april 2018, there was no trend for infection regarding the bd franklin products.Upon the increase of infection reports beginning in april 2018, a corrective and preventive action plan was initiated to address the issue.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.A direct causation between the reported infections and the bd franklin product has not been identified.Prior to the report of infection evaluated in mps-18-1248-sa, there was no trend for infection cases reported for franklin product.This complaint is part of a new trend which began in april 2018.Capa 350041 has been initiated for this issue.Dhr: n/a, no lot no samples and/or pictures were provided.A review of all lot sterility testing performed for product released between april 2015 & june 2018 confirmed that no organism growth was identified for any lots released during the shelf-life of this product.The root cause analysis of the reported infection cases under capa 350041 has not identified a direct causation between the infections and the bd franklin product.
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Search Alerts/Recalls
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