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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML PREFILLED HEPARIN FLUSH SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML PREFILLED HEPARIN FLUSH SYRINGE Back to Search Results
Catalog Number 306510
Device Problems Contamination (1120); Nonstandard Device (1420)
Patient Problem Bacterial Infection (1735)
Event Date 04/12/2018
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
It was reported that a (b)(6) year old patient with a tunneled line who had been diagnosed with heart failure, tested positive for serratia on (b)(6) 2018 and passed away. The patient's discharge summary states that patient's major medical illness was non ischemic cardiomyopathy, mixed septic, cardiogenic shock, hypoxemic respiratory failure, and v-tach arrest. An unspecified bd posiflush¿ heparin lock flush 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. Food and drug administration (fda) and (b)(4) about a potential epidemiological link between catheter related blood stream infections and the s. Marcescens bacterium. Specifically, the fda and (b)(4) 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, (b)(4).
 
Manufacturer Narrative
Additional information: on 7/12/2018, the user facility provided a catalog number for this incident. The updated information is as follows: medical device brand name: 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml. Medical device catalog #: 306510. Unique identifier (udi) #: (b)(4). Pma / 510(k)#: k011967.
 
Event Description
It was reported that a (b)(6) year old patient with a tunneled line who had been diagnosed with heart failure, tested positive for serratia on (b)(6) 2018 and passed away. The patient's discharge summary states that patient's major medical illness was non ischemic cardiomyopathy, mixed septic & cardiogenic shock, hypoxemic respiratory failure, and v-tach arrest. A 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml 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 (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).
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: death. Device single use? no. Device returned to manufacturer: 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 (b)(6) 2018, there was no trend for infection regarding the bd franklin products. Upon the increase of infection reports beginning in (b)(6) 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 june 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 infection and death and the bd franklin product has not been identified.
 
Event Description
"it was reported that a (b)(6) patient with a tunneled line who had been diagnosed with heart failure, tested positive for serratia on (b)(6) 2018 and passed away. The patient's discharge summary states that patient's major medical illness was non ischemic cardiomyopathy, mixed septic & cardiogenic shock, hypoxemic respiratory failure, and v-tach arrest. An unspecified bd posiflush¿ heparin lock flush 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. 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 Name5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML
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 Key7684421
MDR Text Key113863845
Report Number2134319-2018-00099
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011967
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number306510
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 Received06/18/2018
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 Initial

Patient Treatment Data
Date Received: 07/12/2018 Patient Sequence Number: 1
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