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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); Contamination of Device Ingredient or Reagent (2901); Material Integrity Problem (2978)
Patient Problem Bacterial Infection (1735)
Event Date 05/05/2018
Event Type  Injury  
Manufacturer Narrative
Fda notified?: the fda was made aware of this incident via voluntary medwatch mw5077643.This information was communicated to bd on 6/18/2018 by the fda.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 and was positive for serratia marcescens.The patient had central vascular access that was being maintained by an unspecified bd posiflush¿ heparin lock flush syringe.*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.
 
Event Description
It was reported that a patient contracted an infection and was positive for serratia marcescens.The patient had central vascular access that was being maintained by an unspecified bd posiflush¿ heparin lock flush syringe.*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
H.6.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 franklin 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 franklin product has not been identified.Investigation conclusion: the root cause analysis of the reported infection cases under capa 350041 has not identified a direct causation between the infections and the bd franklin product.(b)(4) has been initiated for this issue.
 
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Brand Name
UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
Type of Device
PREFILLED HEPARIN FLUSH SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
9630 south 54th street
franklin WI 53132
MDR Report Key7650719
MDR Text Key112744191
Report Number2134319-2018-00080
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
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
Date Manufacturer Received06/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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