Catalog Number UNKNOWN |
Device Problem
Nonstandard Device (1420)
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Patient Problems
Headache (1880); Nausea (1970)
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Event Date 05/25/2018 |
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.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that a (b)(6) "heart patient" had experienced unusual headaches and nausea for three months.The patient indicated that she had received injections with unspecified bd posiflush¿ normal saline syringes for months.The patient had a consultation at a health clinic and was sent to an emergency department for further evaluation due to her heart condition.The patient was informed that, "everything looked good." the patient did not receive treatment for her headaches or nausea and was not diagnosed with an infection.The patient also had an unspecified procedure scheduled for (b)(6) 2018.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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Event Description
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It was reported that a 68 year old "heart patient" had experienced unusual headaches and nausea for three months.The patient indicated that she had received injections with unspecified bd posiflush¿ normal saline syringes for months.The patient had a consultation at a health clinic and was sent to an emergenc department for further evaluation due to her heart condition.The patient was informed that, "everything looked good." the patient did not receive treatment for her headaches or nausea and was not diagnosed with an infection.The patient also had an unspecified procedure scheduled for (b)(6) 2018.*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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H.6.Investigation summary: prior to the report of infection evaluated in mps-18-1248-sa, there was no trend for infection or reaction cases reported for franklin product.This complaint is part of a new trend which began in april 2018.Capa 350041 was initiated to address this issue.As no lot number was provided, a dhr review could not be completed.Samples and/or pictures were not provided for evaluation.A review of all lot sterility testing performed for product released between april 2015 & may 2018 confirmed that no organism growth was identified for any lots released during the shelf-life of this product.Investigation conclusion: the root cause analysis of the reported infection cases under 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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