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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 Problems Bacterial Infection (1735); Fatigue (1849); Fever (1858); Pain (1994); Weakness (2145)
Event Date 05/15/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. 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 had fever, fatigue, pallor, pain and weakness while using a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 100 usp units/ml at home on her picc line. Two initial sets of cultures were taken and on (b)(6) 2018 were positive for staphylococcus epidermidis. The source was reported to be the patient's picc line but it was not changed. The patient was hospitalized and was treated with iv vancomycin for seven days. The patient was discharged to home and received iv daptomycin for an additional 10 days. As of (b)(6) 2018, the patient indicated that she was still using iv vancomycin and heparin locks through her picc line and anticipated using them for at least another week. 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)(6) about a potential epidemiological link between catheter related blood stream infections and the s. Marcescens bacterium. Specifically, the fda and (b)(6) identified a potential connection between reports of infection in a small number of patients caused by s. Marcescens across multiple states. (b)(6) 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 (b)(6).
 
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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 Key7550772
MDR Text Key109488973
Report Number2134319-2018-00035
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 consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 10/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date08/31/2019
Device Catalogue Number306513
Device Lot Number724472N
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 Received05/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2017
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: 05/29/2018 Patient Sequence Number: 1
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