Catalog Number UNKNOWN |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994); Respiratory Distress (2045); Swelling (2091); Ambulation Difficulties (2544)
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Event Date 06/15/2018 |
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 patient could not breath or move and had pain and swelling in her legs after using an unspecified bd posiflush¿ normal saline syringe.The patient went to a hospital and received an mri on her brain.The patient tested positive for a blood infection but does not know what type.The patient was hospitalized for five weeks and received iv antibiotics.No further information 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: a.3.Patient sex: female.B.2.Event attributed to: required intervention; hospitalization.D.8.Device single use?: no.H.3.Device returned to manufacture: no.Investigation summary: as both a lot number and 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 (b)(6) 2018, there was no trend for infection regarding the bd franklin products.Upon the increase of infection reports beginning in (b)(6) 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.This complaint is part of a new trend which began in (b)(6) 2018.Capa (b)(4) was initiated to address this issue.The root cause analysis of the reported infection cases under capa (b)(4) has not identified a direct causation between the infections and the bd franklin product.
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Event Description
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"it was reported that a patient could not breath or move and had pain and swelling in her legs after using an unspecified bd posiflush¿ normal saline syringe.The patient went to a hospital and received an mri on her brain.The patient tested positive for a blood infection but does not know what type.The patient was hospitalized for five weeks and received iv antibiotics.No further information 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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Search Alerts/Recalls
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