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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 Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Death (1802); Pleural Effusion (2010)
Event Date 04/25/2018
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 had visited multiple hospitals from (b)(6) 2018 - (b)(6) 2018 for blood in stool, leaking heart valve, and fluid in his lungs. The patient received a picc line for antibiotics and an unspecified bd posiflush¿ heparin lock flush syringe was used each day for one week. Cultures were taken and tested positive, but it is not known what the test results showed or what the source of the culture was. The patient was seen by his infectious disease doctor in which it was stated that the patient¿s heart valves were fine, but a week later patient was running a slight fever and sounded as if fluid was in his lungs per the home nurse. The patient saw infectious disease doctor again who had patient transferred to emergency department and was told that his valves were compromised and would need to be replaced. The patient passed away one week later. The spouse of patient stated that cause of death is listed on the death certificate and did not state what the cause of death was. 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
Correction: due to an it issue beginning on 07/03/2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: sex:male. Event attributed to: death. Device single use?: no. Device returned to manufacture: no. 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 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 or related cases reported for (b)(4) product. The complaint is part of a new trend which began in april 2018. Capa (b)(4) was initiated to address infection and related cases. As a lot number was not provided, a dhr review could not be completed. No samples or pictures were returned. 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. The root cause analysis of the reported infection and related cases under capa (b)(4) has not identified a direct causation between the infections and the bd (b)(4) product.
 
Event Description
It was reported that a patient had visited multiple hospitals from (b)(6) 2018 - (b)(6) 2018 for blood in stool, leaking heart valve, and fluid in his lungs. The patient received a picc line for antibiotics and an unspecified bd posiflush¿ heparin lock flush syringe was used each day for one week. Cultures were taken and tested positive, but it is not known what the test results showed or what the source of the culture was. The patient was seen by his infectious disease doctor in which it was stated that the patient¿s heart valves were fine, but a week later patient was running a slight fever and sounded as if fluid was in his lungs per the home nurse. The patient saw infectious disease doctor again who had patient transferred to emergency department and was told that his valves were compromised and would need to be replaced. The patient passed away one week later. The spouse of patient stated that cause of death is listed on the death certificate and did not state what the cause of death was. *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 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 Key7672137
MDR Text Key113503044
Report Number2134319-2018-00086
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
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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
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: 07/09/2018 Patient Sequence Number: 1
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