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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE

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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.
 
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Brand Name10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
Type of DevicePREFILLED SALINE FLUSH SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
9630 south 54th street
franklin WI 53132
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
9630 south 54th street
franklin WI 53132
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7550747
MDR Text Key109483656
Report Number2134319-2018-00032
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date06/07/2020
Device Catalogue Number306500
Device Lot Number715911C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
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