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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, 100 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, 100 USP UNITS/ML PREFILLED HEPARIN FLUSH SYRINGE Back to Search Results
Catalog Number 306513
Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 03/20/2018
Event Type  Injury  
Manufacturer Narrative
Ten lot numbers were provided for this incident. The information for each lot number is as follows: medical device lot #: 709682n medical device expiration date: 4/5/2019 device manufacture date: 4/11/2017 medical device lot #: 710391n medical device expiration date: 4/12/2019 device manufacture date: 4/20/2017 medical device lot #: 712391n medical device expiration date: 5/2/20109 device manufacture date: 5/9/2017 medical device lot #: 718771n medical device expiration date: 7/5/2019 device manufacture date: 7/8/2017 medical device lot #: 719172n medical device expiration date: 7/9/2019 device manufacture date: 7/12/2017 medical device lot #: 719271n medical device expiration date: 7/10/2019 device manufacture date: 7/14/2017 medical device lot #: 720072n medical device expiration date: 7/18/2019 device manufacture date: 7/21/2017 medical device lot #: 725171n medical device expiration date: 9/7/2019 device manufacture date: 9/11/2017 medical device lot #: 726811n medical device expiration date: 9/24/2019 device manufacture date: 9/27/2017 medical device lot #: 725711n medical device expiration date: 9/13/2019 device manufacture date: 9/19/2017 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 the cdc confirmed a case of serratia marcescens bloodstream infection from (b)(6) with pfge patterns indistinguishable from the original co outbreak pattern. The patient is a (b)(6) male diagnosed with lymphoma and is immunocompromised with an implanted port that was accessed in an outpatient infusion clinic. The patient presented to a hospital with positive serratia marcescens culture on (b)(6) 2018, was treated, and subsequently discharged. The specific treatment provided is unknown. The device implicated with this incident is a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 100 usp units/ml. *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, 100 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 Key7541297
MDR Text Key109220737
Report Number2134319-2018-00027
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
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number306513
Device Lot NumberSEE H.10.
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 Received05/11/2018
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: 05/24/2018 Patient Sequence Number: 1
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