BECTON DICKINSON MEDICAL SYSTEMS 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE
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Catalog Number 306513 |
Device Problems
Nonstandard Device (1420); Microbial Contamination of Device (2303)
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Patient Problems
Bacterial Infection (1735); Death (1802)
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Event Date 06/28/2018 |
Event Type
Death
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Manufacturer Narrative
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Date of event: unknown.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 between march and april of 2018, a patient received multiple heparin flushes with a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 100 usp units/ml.In early (b)(6), the patient passed away.There was no report of infection or additional information regarding this patient's death.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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Manufacturer Narrative
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Additional information: please note that some of the aeg questions have been updated due to a response from the customer.Cause of death was determined to be pneumonia, heart failure.No medical intervention or other actions were taken as a result.Course of treatment was not changed.Culture was taken (b)(6) with no growth after five days.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: event attributed to: death.Device single use?: no.Device returned to manufacture: no.Investigation summary: as both a lot number and a sample were unavailable 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 or death 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 may 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 deaths and the bd franklin product has not been identified.
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Event Description
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It was reported that between (b)(6) and (b)(6) of 2018, a patient received multiple heparin flushes with a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 100 usp units/ml.In early (b)(6), the patient passed away.There was no report of infection or additional information regarding this patient's death.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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Search Alerts/Recalls
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