BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE
|
Back to Search Results |
|
Catalog Number 306500 |
Device Problems
Nonstandard Device (1420); Microbial Contamination of Device (2303)
|
Patient Problems
Bacterial Infection (1735); Death (1802)
|
Event Date 02/04/2018 |
Event Type
Death
|
Manufacturer Narrative
|
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
A consumer reported that her sister had an infection and passed away on (b)(6) 2018.A 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe was implicated with this incident.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.
|
|
Manufacturer Narrative
|
Investigation summary: lot number 715911c for product code 306500 was provided for evaluation by our quality engineer team.Upon reviewing the production history for the provided lot number, no deviations or non-conformances were identified during the manufacturing process.A corrective and preventive action plan was initiated to further investigate and monitor this issue.One-hundred and twenty retained samples for the lot number provided were visually inspected and no abnormalities were observed in regards to the solution.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.Multiple samples produced before and after the provided lot number were sent for sterility testing and confirmed that no microbial growth was exhibited after incubation.This in combination with the daily environmental monitoring and sterility testing provides confidence in the sterility of the reported lot number.A direct causation between the reported infections and death and the bd (b)(4) product has not been identified.Prior to the report of infection evaluated in (b)(4), there was no trend for infection cases reported for (b)(4) product.This complaint is part of a new trend which began in april 2018.Capa (b)(4) was initiated to address this issue.Dhr: there were no deviations, non-conformances, or out of specification conditions related to the manufacture of lot 715911c 120 retained samples were 100% visually inspected.No growth was seen (i.E., solution was clear).Lot 715911c was manufactured between tested lots 705311b and 716192n, both of which exhibited no growth during the confirmatory sterility testing.This, in combination with the daily environmental monitoring and original sterility testing for the lot release, provides confidence in the sterility of the complaint lot.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.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 (b)(4) product.
|
|
Event Description
|
A consumer reported that her sister had an infection and passed away on (b)(6) 2018.A 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe was implicated with this incident.*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.
|
|
Search Alerts/Recalls
|
|
|