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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 Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Fever (1858); Vomiting (2144)
Event Date 06/15/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a patient contracted an infection due to bacteria in his blood and experienced vomiting and a fever. The patient was hospitalized for five days and received an mri and ct scan. The use of a 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe was associated 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. (b)(4) about a potential epidemiological link between catheter related blood stream infections and the s. Marcescens bacterium. Specifically, the (b)(4) identified a potential connection between reports of infection in a small number of patients caused by s. Marcescens across multiple states. (b)(4)¿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, (b)(4).
 
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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 Key7660369
MDR Text Key113150374
Report Number2134319-2018-00081
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
Type of Report Initial,Followup,Followup
Report Date 10/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date10/23/2020
Device Catalogue Number306500
Device Lot Number729711A
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 Received06/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2017
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: 07/03/2018 Patient Sequence Number: 1
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