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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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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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