BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7571114 · Received June 5, 2018

    Report

    Report Number
    2134319-2018-00045
    Event Type
    Injury
    Date Received
    June 5, 2018
    Date of Event
    April 29, 2018
    Report Date
    August 23, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FOZ
    UDI-DI
    30382903065005
    PMA / PMN Number
    K011982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LOT NUMBER: 714411A FOR PRODUCT CODE: 306500 WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON REVIEWING THE PRODUCTION HISTORY FOR THE PROVIDED LOT NUMBER, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. A CORRECTIVE AND PREVENTIVE ACTION PLAN WAS INITIATED TO FURTHER INVESTIGATE AND MONITOR THIS ISSUE. PRIOR TO THE REPORT OF INFECTION EVALUATED IN MPS-18-1248-SA, THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR FRANKLIN PRODUCT. THIS COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 2018. THERE WERE NO DEVIATIONS, NON-CONFORMANCES, OR OUT OF SPECIFICATION CONDITIONS NOTED DURING THE MANUFACTURE OF LOT: 714411A 100% OF RETAINED SAMPLES FOR THE LOT: (B)(4) UNITS) WERE VISUALLY INSPECTED. NO GROWTH WAS SEEN (I.E., THE SOLUTION WAS CLEAR). LOT: 74411A WAS MANUFACTURED BETWEEN LOTS: 705311B AND 716192N, BOTH OF WHICH EXHIBITED NO GROWTH DURING THE CONFIRMATORY STERILITY TESTING. THIS, IN COMBINATION WITH THE DAILY ENVIRONMENTAL MONITORING AND ORIGINAL STERILITY TESTING FOR THE LOT RELEASE, PROVIDES CONFIDENCE IN THE STERILITY OF THE COMPLAINT LOT. A REVIEW OF ALL LOT STERILITY TESTING PERFORMED FOR PRODUCT RELEASED BETWEEN APRIL 2015 & JUNE 2018 CONFIRMED THAT NO ORGANISM GROWTH WAS IDENTIFIED FOR ANY LOTS RELEASED DURING THE SHELF-LIFE OF THIS PRODUCT. THIS IN COMBINATION WITH THE DAILY ENVIRONMENTAL MONITORING AND STERILITY TESTING PROVIDES CONFIDENCE IN THE STERILITY OF THE REPORTED LOT NUMBER. THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION CASES UNDER CAPA: 350041 HAS NOT IDENTIFIED A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD FRANKLIN PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2018 THROUGH ON (B)(6) 2018 BECAUSE SHE DEVELOPED TWO INFECTIONS. THE PATIENT INDICATED THAT THE INFECTIONS WERE ASSOCIATED WITH THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. INFORMATION ABOUT SPECIFIC TREATMENT PROVIDED IN THE HOSPITAL WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2018 THROUGH (B)(6) 2018 BECAUSE SHE DEVELOPED TWO INFECTIONS. THE PATIENT INDICATED THAT THE INFECTIONS WERE ASSOCIATED WITH THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. INFORMATION ABOUT SPECIFIC TREATMENT PROVIDED IN THE HOSPITAL WAS NOT PROVIDED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410463 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE FOZ BECTON DICKINSON MEDICAL SYSTEMS 714411A 30382903065005

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization