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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE PREFILLED HEPARIN FLUSH SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE PREFILLED HEPARIN FLUSH SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 03/11/2018
Event Type  Death  
Manufacturer Narrative
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.
 
Event Description
It was reported that a patient who was diagnosed with lymphoma and being treated with chemotherapy developed thrombosis and was admitted to a hospital. The patient became quite ill in the hospital and eventually passed away. The patient's father claimed that the cause of death was a bacterial infection that he indicated, "no one knows where it came from," but he believes it is associated with an unspecified bd posiflush¿ heparin lock flush syringe that was used two time per day for five days. 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: 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 april 2018, there was no trend for infection regarding the bd (b)(4) products. Upon the increase of infection reports beginning in april 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. A direct causation between the reported infections and the bd (b)(4) product has not been identified. Investigation conclusion: unknown ¿ lot number was not provided 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. As no lot number was provided, a dhr review could not be completed. Quantity of retained samples used for testing: 0 ¿ although retain samples are available for all lots manufactured in (b)(4), as the lot number was not provided, retain samples were not tested. A review of all lot sterility testing performed for product released between april 2015 & may 2018 confirmed that no organism growth was identified for any lots released during the shelf-life of this product. Conclusion(s): 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.
 
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Brand NameUNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
Type of DevicePREFILLED HEPARIN 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 Key7587397
MDR Text Key110632739
Report Number2134319-2018-00042
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/11/2018 Patient Sequence Number: 1
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