BEUDAMED
    FDA Adverse Event Death Summary report: N

    10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE

    MDR report key: 7571837 · Received June 5, 2018

    Report

    Report Number
    2134319-2018-00046
    Event Type
    Death
    Date Received
    June 5, 2018
    Date of Event
    January 10, 2018
    Report Date
    June 28, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    UDI-DI
    30382903065180
    PMA / PMN Number
    K011982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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 (CAPA (B)(4)) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD SURGERY FOR AN ABSCESS ON (B)(6) 2018. WHILE HOSPITALIZED, THE PATIENT WAS TREATED WITH 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGES, IN 10 ML SYRINGE WITH BD¿ BLUNT PLASTIC CANNULA. THE PATIENT WAS RELEASED AND PRESCRIBED 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGES, IN 10 ML SYRINGE WITH BD¿ BLUNT PLASTIC CANNULA AS WELL. THE PATIENT ALSO HAD SEVERAL BLOOD AND OTHER TESTS AT THE HOSPITAL. ULTIMATELY, THE PATIENT EXPIRED FROM SEPSIS ON (B)(6) 2018. 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. (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, FDA, AND (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410683 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903065180

    Patients

    Seq Age Sex Outcome Treatment
    1 Death